Head and Neck Squamous Cell CarcinomaPhase 3HOPENCT06992427
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
A Phase 3 study testing Gabapentin, Chemotheraphy and Radiation Therapy in people with Head and Neck Squamous Cell Carcinoma and Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, run by Alliance for Clinical Trials in Oncology at 212 sites in United States.
Trial summary
This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- What is being tested?
- Gabapentin, Chemotheraphy and Radiation Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 212 sitesUnited States
- Study dates
- 5 Jun 2025to 15 Apr 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic documentation of disease: Squamous cell carcinoma of the head and neck region.
- Stage: I-IV
- No prior treatment for head and neck cancer
- Planned treatment with cisplatin-based chemoradiation therapy (weekly or once every 3 weeks [q 3 week])
- Able to swallow capsules whole
- No known hypersensitivity to gabapentin or its ingredients
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- No patients on dialysis or with transplanted organs
- No prior surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer. Patients with a history of surgery and radioactive iodine for the treatment of thyroid cancer are eligible. Concurrent cancer therapy for other cancers is not allowed
- No planned surgery or chemotherapy or immunotherapy following 7 weeks of standard chemoradiation treatment
- No known brain metastases
- No nonprescribed use of any opioids (including heroin) within 6 months prior to registration
- No prescribed medications for chronic and/or long-term pain and/or neuropathy, including patients under treatment of a pain specialist or substance abuse programs. Acute post-biopsy medications are allowed if the patient has discontinued them 3 days prior to study registration
- No current treatment with mefloquine
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- Not pregnant and not nursing, because this study involves both radiation and chemotherapy. In addition, the genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential, a negative pregnancy test done < 7 days prior to registration is required. Women must agree to using contraception for the duration of receiving study drugs and for 6 months after completing chemoradiation
- Not taking medications for a psychotic psychiatric illness
- No existing diagnosis of sleep apnea
- No acute narrow-angle glaucoma
- No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- No investigational agent within 30 days prior to registration
- No enrollment on other studies of systemic pain control agents
- Language: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish
- Patients with impaired decision making are not eligible for study
Who cannot join
- -
Trial locations and contacts
212 sites in 1 country. Contact the study team or a site near you to ask about taking part.
212 sites in 1 country
United States212 sites, 187 recruiting
- Recruiting
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Site Public Contact, 855-776-0015
Lisa A. McGee
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Site Public Contact, 207-626-4855
Vatche Tchekmedyian
- Recruiting
Rush-Copley Medical Center
Aurora, Illinois, 60504
Site Public Contact, 630-978-6212, RCMC_Cancer_Research@rush.edu
Daniel H. Barnett
- Recruiting
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Site Public Contact, ncorp@aah.org
Thomas J. Saphner
- Recruiting
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301
Site Public Contact, 661-323-4673
Luis Mariscal
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Thomas J. Saphner
- Recruiting
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Vatche Tchekmedyian
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Weining Zhen
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
David A. Clump
- Recruiting
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, 04011
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Vatche Tchekmedyian
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Anurag K. Singh
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Daniel C. Sufficool
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402
Site Public Contact, 319-368-5514, Rachel.varner@unitypoint.org
Candace R. Correa
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Voichita Bar Ad
- Recruiting
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
John M. Schallenkamp
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Thomas J. Saphner
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Mackenzie D. Daly
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Mackenzie D. Daly
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Sung Jun Ma
- Active, not recruiting
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Thomas J. Saphner
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
MaineHealth LincolnHealth Hospital
Damariscotta, Maine, 04543
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Vatche Tchekmedyian
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Daniel H. Barnett
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Fiori Alite
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu
Fiori Alite
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Thomas J. Saphner
- Active, not recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
- Recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Site Public Contact, 855-776-0015
Lisa A. McGee
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Daniel H. Barnett
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Thomas J. Saphner
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Dan P. Zandberg
- Recruiting
Saint Vincent Hospital
Erie, Pennsylvania, 16544
Site Public Contact, 814-452-5000
Larisa Greenberg
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Farmington Health Center
Farmington, Utah, 84025
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Ying J. Hitchcock
- Recruiting
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Dan P. Zandberg
- Recruiting
Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York, 11375
Site Public Contact, 718-520-6620
Bhupesh Parashar
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Active, not recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
- Active, not recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, 85297
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Cory W. Heal
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Site Public Contact, 724-838-1900
Dan P. Zandberg
- Recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Amarinthia (Amy) Curtis
- Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org
Dan P. Zandberg
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Thomas J. Saphner
- Active, not recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Recruiting
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
Site Public Contact, 412-359-3043, ddefazio@wpahs.org
Larisa Greenberg
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
CHI Health Good Samaritan
Kearney, Nebraska, 68847
- Recruiting
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Michael O. Ojelabi
- Recruiting
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Site Public Contact, 855-776-0015
Lisa A. McGee
- Recruiting
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Bhupesh Parashar
- Recruiting
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, 80228
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Shahzad Siddique
- Recruiting
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu
Fiori Alite
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Thomas J. Saphner
- Recruiting
Condell Memorial Hospital
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Thomas J. Saphner
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Santanu Samanta
- Recruiting
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu
Adam Garsa
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Adam Garsa
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
Site Public Contact, 855-776-0015
Lisa A. McGee
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
David A. Clump
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Daniel H. Barnett
- Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Dan P. Zandberg
- Recruiting
Aspirus Medford Hospital
Medford, Wisconsin, 54451
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Monica E. Shukla
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Monica E. Shukla
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Active, not recruiting
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356
- Active, not recruiting
Kaiser Permanente-Modesto
Modesto, California, 95356
- Suspended
Trinity Medical Center
Moline, Illinois, 61265
- Recruiting
Forbes Hospital
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-858-7746
Larisa Greenberg
- Recruiting
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Dan P. Zandberg
- Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Dan P. Zandberg
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
David A. Clump
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Site Public Contact, 212-434-4460
Bhupesh Parashar
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Site Public Contact, 516-734-8896
Bhupesh Parashar
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Daniel H. Barnett
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Daniel H. Barnett
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Monica E. Shukla
- Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Site Public Contact, 800-323-8622
Thomas J. Saphner
- Recruiting
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
Site Public Contact, ncorp@aah.org
Thomas J. Saphner
- Active, not recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Christina Henson
- Active, not recruiting
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
- Recruiting
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Site Public Contact, 402-559-5600
Weining Zhen
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Weining Zhen
- Recruiting
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Advocate High Tech Medical Park
Palos Heights, Illinois, 60463
Site Public Contact, ncorp@aah.org
Thomas J. Saphner
- Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Site Public Contact, 847-384-3621
Thomas J. Saphner
- Recruiting
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
David A. Clump
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381
Site Public Contact, 623-773-2873
Cory W. Heal
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
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Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
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Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
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Arizona Center for Cancer Care - Biltmore
Phoenix, Arizona, 85016
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Cory W. Heal
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Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, 85027
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Cory W. Heal
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Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Site Public Contact, 855-776-0015
Lisa A. McGee
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Pittsburgh, Pennsylvania, 15212
Site Public Contact, 877-284-2000
Larisa Greenberg
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Dan P. Zandberg
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UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-621-2334
Dan P. Zandberg
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UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
Site Public Contact, 412-502-3920
Dan P. Zandberg
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MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Vatche Tchekmedyian
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Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
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Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
Site Public Contact, 800-275-6401, cancerresearch@geisinger.edu
Fiori Alite
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Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
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Princeton Community Hospital
Princeton, West Virginia, 24740
Site Public Contact, 304-487-7515
David A. Clump
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Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
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Queens Cancer Center
Rego Park, New York, 11374
Site Public Contact, 718-312-3446
Bhupesh Parashar
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Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin, 54501
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Site Public Contact, 855-776-0015
Lisa A. McGee
- Active, not recruiting
Kaiser Permanente-Roseville
Roseville, California, 95661
- Active, not recruiting
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
- Active, not recruiting
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
- Recruiting
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Site Public Contact, 877-229-4907, coborncancercenter@centracare.com
Donald J. Jurgens
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University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Ying J. Hitchcock
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Ying J. Hitchcock
- Active, not recruiting
Kaiser Permanente-San Francisco
San Francisco, California, 94115
- Active, not recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
- Active, not recruiting
Kaiser Permanente San Leandro
San Leandro, California, 94577
- Active, not recruiting
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
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Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
Site Public Contact, 207-459-1600
Vatche Tchekmedyian
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Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
- Active, not recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
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MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Vatche Tchekmedyian
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Arizona Center for Cancer Care - Osborn
Scottsdale, Arizona, 85251
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Cory W. Heal
- Recruiting
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, 85258
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Cory W. Heal
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UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346
Site Public Contact, 814-676-7900
Dan P. Zandberg
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Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
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Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Daniel Almquist
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South Jordan Health Center
South Jordan, Utah, 84009
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Ying J. Hitchcock
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MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Vatche Tchekmedyian
- Active, not recruiting
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
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Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Amarinthia (Amy) Curtis
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Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
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Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
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Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
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Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net
Jay W. Carlson
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Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Recruiting
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org
Andrew J. Huang
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Public Contact, 800-862-2215
Kartik M. Mani
- Recruiting
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, 85374
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Cory W. Heal
- Recruiting
Arizona Center for Cancer Care
Tempe, Arizona, 85284
Site Public Contact, 480-278-8261, penny.labriola@arizonaccc.com
Cory W. Heal
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Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Rafi Kabarriti
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Rafi Kabarriti
- Recruiting
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Daniel H. Barnett
- Active, not recruiting
Kaiser Permanente-Vallejo
Vallejo, California, 94589
- Active, not recruiting
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
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Aspirus Cancer Care-Wausau
Wausau, Wisconsin, 54401
Site Public Contact, 877-405-6866
Andrew J. Huang
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Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
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Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
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Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Monica E. Shukla
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Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090
Site Public Contact, Dawnmarie.DeFazio@ahn.org
Larisa Greenberg
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Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003
Site Public Contact, 304-243-6442
David A. Clump
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Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu
Fiori Alite
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Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
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Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
Site Public Contact, 715-422-7718
Andrew J. Huang
About this study
Official title: High-Dose Prophylactic Gabapentin (HOPE) to Prevent Opioid Use for Oral Mucositis Pain During Head and Neck Chemoradiotherapy: A Phase III Clinical Trial
This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Oral mucositis is a common side effect of radiation treatment and can cause severe pain, dysphagia, and weight loss resulting in feeding tube placement, worse health-related quality of life, treatment interruptions, unplanned hospitalizations, and significant financial burden. Mucositis pain is often treated with opioid pain medications which do provide pain relief but have many known side effects not limited to mental clouding, constipation, fatigue, endocrinopathy, neurotoxicity, sleep-disordered breathing, and most distressingly persistent opioid use. Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving chemotherapy and radiation for squamous cell carcinoma of the head and neck region
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether prophylactic high dose gabapentin, titrated to a dose of 3600 mg (1200 mg three times per day [TID]), is superior to placebo in increasing the proportion of patients not needing opiates while undergoing chemoradiation therapy.
SECONDARY OBJECTIVES:
- To determine whether prophylactic high dose gabapentin is superior to placebo in prolonging the time to first opioid use while undergoing chemoradiation therapy.
II. To determine whether prophylactic high dose gabapentin is superior to placebo in improving patient reported pain scores using the 0-10 numerical rating scale (NRS) from baseline to 4 weeks after the end of chemoradiation therapy.
EXPLORATORY OBJECTIVES:
- To explore the duration of opioid use from the time of initiation to cessation by arm as well as describe the proportion of patients remaining on opioids at 3 months, 6 months, and 1 year by arm.
II. To explore the trajectory of patient reported symptom and quality of life outcomes using the Oral Mucositis Weekly Questionnaire (OMWQ) by arm.
III. To explore the trajectory of patient reported symptom and quality of life outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-30) by arm.
IV. To explore the trajectory of patient reported symptom and quality of life outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck-43 (EORTC QLQ-H\&N43) by arm.
- To evaluate the adverse event profiles of prophylactic high dose gabapentin versus placebo.
VI. To assess the tolerance of high dose gabapentin. VII. To explore the trajectory of patient health using patient body mass index (BMI) and creatinine, absolute neutrophil count (ANC) as routinely obtained by arm.
VIII. To describe the incidence of feeding tube requirement during and after chemoradiation therapy by arm.
IX. To describe the dose of prescribed opioids standardized using the Morphine Milligram Equivalent calculator by arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Starting by radiation treatment 8, patients receive placebo orally (PO) once daily (QD) on day 1, twice daily (BID) on day 2, then three times daily (TID) starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with placebo continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive placebo TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.
ARM II: Starting by radiation treatment 8, patients receive gabapentin PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with gabapentin continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive gabapentin TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 4 weeks, 3 months and 6 months after the last dose of chemoradiation therapy.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8, Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Being tested
- Gabapentin, Placebo, Chemotheraphy, Radiation Therapy, Analgesic Agent
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Gralise, Neurontin
Given PO
PlaceboDrug
Given PO
ChemotheraphyDrug
Receive standard of care chemotherapy
Radiation TherapyRadiation
Undergo standard of care radiation
Analgesic AgentDrug
Receive standard of care pain medication
Biospecimen CollectionProcedure or surgery
Undergo blood sample collection
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Placebo) | Placebo comparator | Starting by radiation treatment 8, patients receive placebo PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with placebo continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive placebo TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study. Receives: Drug: Placebo; Drug: Chemotheraphy; Radiation: Radiation Therapy; Drug: Analgesic Agent; Procedure: Biospecimen Collection; Other: Survey Administration |
| Arm II (Gabapentin) | Experimental | Starting by radiation treatment 8, patients receive gabapentin PO QD on day 1, BID on day 2, then TID starting day 3 onward. Patients also receive standard of care radiation, chemotherapy and pain medications. Treatment with gabapentin continues in the absence of disease progression or unacceptable toxicity, until the symptoms of oral mucositis and other treatment effects begin to resolve and other pain medications has been stopped. Patients then continue to receive gabapentin TID for 9 additional days, at sequentially smaller doses, then BID for 1 day and QD for one day before stopping. Patients undergo blood sample collection throughout the study. Receives: Drug: Gabapentin; Drug: Chemotheraphy; Radiation: Radiation Therapy; Drug: Analgesic Agent; Procedure: Biospecimen Collection; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need to use opioids during chemoradiation therapy (CRT)
Will be tested using a two-sample test of proportions. Will report the proportion of patients not using opioids within the 7 weeks of CRT in the two arms and the 95% confidence interval (CI) of the difference in the proportions.
Measured: Up to 7 weeks
Secondary outcomes (2)
Time to first opioid use
Time to first opioid use, defined as the time from randomization to the first occurrence of opioid use during CRT, censoring patients alive and opioid free at CRT completion. Death or disease progression before first opioid use during CRT will be treated as competing events. Cumulative incidence functions will be used to estimate the percentage of patients who experience the competing events within the arms. Differences between the cumulative incidence functions between the arms will be tested for statistical significance using the procedure of Gray. The cumulative incidence percentage at the end of CRT by arm will be reported.
Measured: Up to 9 weeks
Patient-reported pain scores
Pain score responses of question #5 on the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN) survey at each collected timepoint for each arm. This NRS item asks a respondent to rate their overall mouth and throat soreness during the past week from 0 (no soreness) to 10 (worst possible soreness). Will apply longitudinal modeling of the patient-reported pain scores through four weeks post CRT treatment. Will report each time-specific comparison between arms with a 95% CI.
Measured: Through 4 weeks post CRT (up to 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start5 Jun 2025
- Primary completion15 Aug 2029 (estimated)
- Study completion15 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992427
- Sponsor's protocol ID
- A222301
- Other IDs
- NCI-2025-00501
- Acronym
- HOPE
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided