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Breast CancerPhase 3NCT00087399

Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy

A Phase 3 study testing gabapentin and antidepressant in people with Breast Cancer and Hot Flashes, run by Alliance for Clinical Trials in Oncology at 162 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Hot Flashes
What is being tested?
gabapentin and antidepressant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
162 sitesUnited States
Study dates
Nov 2004to Apr 2007
Phase
Phase 3
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • History of breast cancer OR a concern about taking hormonal therapy due to a fear of developing breast cancer
  • Experiencing bothersome hot flashes, defined as patient-reported occurrence ≥ 14 times per week AND sufficiently severe to prompt desire for additional therapeutic intervention despite current use of an antidepressant
  • Currently (≥ 2 weeks) being treated with a stable dose of an antidepressant
  • No monoamine oxidase inhibitors or tricyclics
  • No current evidence of malignant disease
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • More than 4 weeks since prior antineoplastic chemotherapy
  • No concurrent antineoplastic chemotherapy

Endocrine therapy

  • More than 4 weeks since prior androgens, estrogens, or progestational agents
  • More than 2 weeks since prior dehydroepiandrosterone (DHEA) for treatment of hot flashes
  • No concurrent androgens, estrogens, or progestational agents, including oral contraceptives
  • No concurrent DHEA for treatment of hot flashes
  • Concurrent tamoxifen, raloxifene, or aromatase inhibitor therapy allowed if on a stable dose for at least 4 weeks prior to study entry and during study treatment

Other

  • No prior gabapentin
  • More than 2 weeks since other prior treatment for hot flashes (e.g., clonidine or Bellergal-S®)
  • Concurrent vitamin E or soy supplements allowed if on a stable dose for at least 1 month prior to study entry and during study treatment
  • No other concurrent treatment for hot flashes (e.g., clonidine or Bellergal-S®)
  • No other concurrent antidepressants

Trial locations and contacts

162 sites in 1 country.

162 sites in 1 country

United States162 sites

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48100

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • MeritCare Clinic - Bemidji

    Bemidji, Minnesota, 56601

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Health System

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, P.C.

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58501

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Brainerd Medical Center

    Brainerd, Minnesota, 56401

  • St. Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Community Hospital

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Memorial Hospital

    Carthage, Illinois, 62321

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Hospital

    Eureka, Illinois, 61530

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Medical Group

    Fargo, North Dakota, 58122

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48532

  • Fremont Area Medical Center

    Fremont, Nebraska, 68025

  • Mercy and Unity Cancer Center at Mercy and Unity Hospitals

    Fridley, Minnesota, 55432

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • Green Bay Oncology, Limited at St. Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center

    Green Bay, Wisconsin, 54303

  • Mason District Hospital

    Havana, Illinois, 62644

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Green Bay Oncology, Limited - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224-9980

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Bryan LGH Medical Center West

    Lincoln, Nebraska, 68502

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • St. Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • St. John's Hospital

    Maplewood, Minnesota, 55109

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59802

  • Alegent Health Community Memorial Hospital

    Missouri Valley, Iowa, 51555

  • Trinity Medical Center - East

    Moline, Illinois, 61265

  • Chippewa County - Montevideo Hospital

    Montevideo, Minnesota, 56265

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Cancer Center at Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Burgess Health Center

    Onawa, Iowa, 51040

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois - Ottawa

    Ottawa, Illinois, 61350

  • Cancer Center at Ottumwa Regional Health Center

    Ottumwa, Iowa, 52501

  • Midlands Cancer Center at Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61615

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Pratt Cancer Center of Kansas

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • Adult and Pediatric Urology, P.L.L.P.

    Saint Cloud, Minnesota, 56303

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic

    Saint Louis Park, Minnesota, 55416

  • Cancer Care Center at Regions Hospital

    Saint Paul, Minnesota, 55101

  • St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67042

  • Guthrie Medical Center - Sayre

    Sayre, Pennsylvania, 18840

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259

  • Saint Francis Cancer Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101-1733

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57104

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29304

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • St. John Macomb Hospital

    Warren, Michigan, 48903

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Medical Oncology and Hematology Associates - West Des Moines

    West Des Moines, Iowa, 50266

  • Associates in Womens Health

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, P.A.

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Woodwinds Hospital

    Woodbury, Minnesota, 55125

  • United States Air Force Medical Center Wright-Patterson

    Wright-Patterson AFB, Ohio, 45433-5529

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone

RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes.

PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of gabapentin with vs without an antidepressant, as measured by the frequency and intensity of hot flashes, in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer.
  • Compare adverse events in patients treated with these regimens.
  • Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity.
  • Arm II: Patients receive gabapentin as in arm I. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone (per arm I schedule).

Patients in both arms complete a hot flash diary at baseline and then daily during study treatment.

Quality of life is assessed at baseline and then weekly during study treatment.

PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.

Being tested
gabapentin, antidepressant
Keywords
breast cancer, hot flashes
Medical subject headings
Breast Neoplasms, Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00087399
Study groupRoleWhat they receive
gabapentin + antidepressantExperimentalPatients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients complete a hot flash diary at baseline and then daily during study treatment.
Receives: Drug: gabapentin; Drug: antidepressant
gabapentinExperimentalPatients receive gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone. Patients complete a hot flash diary at baseline and then daily during study treatment.
Receives: Drug: gabapentin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hot flash reduction by diary record at 4 weeks

    Measured: at 4 weeks

Secondary outcomes (1)

  1. Toxicity by questionnaires at 4 weeks

    Measured: at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startNov 2004
  3. Primary completionApr 2007
  4. Study completionApr 2007

Resources

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
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087399
Sponsor's protocol ID
NCCTG-N03C5
Other IDs
NCI-2012-02616, CDR0000374993
Status last verified
Jul 2016
First submitted
8 Jul 2004
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Loprinzi CL, Kugler JW, Barton DL, Dueck AC, Tschetter LK, Nelimark RA, Balcueva EP, Burger KN, Novotny PJ, Carlson MD, Duane SF, Corso SW, Johnson DB, Jaslowski AJ. Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone: NCCTG N03C5. J Clin Oncol. 2007 Jan 20;25(3):308-12. doi: 10.1200/JCO.2006.07.5390. Epub 2006 Dec 4.

    PubMed 17146104

  • Loprinzi CL, Kugler JW, Barton DL, et al.: Phase III randomized trial to evaluate the use of gabapentin alone vs with continuing an antidepressant in women failing an antidepressant for the treatment of hot flashes: North Central Cancer Treatment Group study N03C5. [Abstract] J Clin Oncol 24 (Suppl 18): A-526, 9s, 2006.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gabapentin and antidepressant in people with Breast Cancer and Hot Flashes, run by Alliance for Clinical Trials in Oncology at 162 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hot flash reduction by diary record at 4 weeks (time frame: at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00087399, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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