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Hematopoietic/Lymphoid CancerPhase 3NCT02116530

Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

A Phase 3 study testing Olanzapine, Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) and Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant) in people with Hematopoietic/Lymphoid Cancer and Nausea and Vomiting, run by Alliance for Clinical Trials in Oncology at 177 sites in United States.

Completed

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

Official record

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Trial summary

This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Olanzapine, Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) and Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
401 participants
Where
177 sitesUnited States
Study dates
20 Aug 2014to 15 Jun 2017
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
  • Diagnosis of malignant disease
  • No prior chemotherapy and scheduled to receive HEC (either cisplatin-containing regimen or anthracycline + cyclophosphamide [AC])
  • Cisplatin at a dose of ≥70mg/m^2, with or without other chemotherapy agent(s) OR
  • Anthracycline (60 mg/m^2) plus cyclophosphamide(600 mg/m^2)
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
  • Required Initial Laboratory Values ≤ 120 days prior to registration
  • Serum Creatinine ≤2.0 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic oxaloacetic transaminase (SGPT) ≤3 x Upper Limit of Normal (ULN)
  • Absolute neutrophil count (ANC) ≥1500/mm^3
  • No nausea or vomiting ≤ 24 hours prior to registration
  • Negative pregnancy test (serum or urine) done ≤7 days prior to registration, for women of childbearing potential only (per clinician discretion)
  • No severe cognitive compromise
  • No known history of CNS disease (e.g. brain metastases, seizure disorder)
  • No treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to registration or planned during protocol therapy
  • No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy)
  • No concurrent use of amifostine
  • No concurrent abdominal radiotherapy
  • No concurrent use of quinolone antibiotic therapy
  • No chronic alcoholism (as determined by the investigator)
  • No known hypersensitivity to olanzapine
  • No known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months.
  • No history of uncontrolled diabetes mellitus (e.g. on insulin or an oral hypoglycemic agent)

Trial locations and contacts

177 sites in 1 country.

177 sites in 1 country

United States177 sites

  • Oncare Hawaii Inc-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Leeward

    ‘Ewa Beach, Hawaii, 96706

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Regional Hospital

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Central Vermont Medical Center

    Berlin Corners, Vermont, 05602

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wisconsin, 82001

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80901

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45420

  • Florida Hospital Memorial Medical Center

    Daytona Beach, Florida, 32117

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80907

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Mercy Medical Center-Sioux City

    Des Moines, Iowa, 51102

  • Epic Care-Dublin

    Dublin, California, 94568

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Hardin Memorial Hospital

    Elizabethtown, Kentucky, 42701

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Comprehensive Cancer Care and Research Institute of Colorado LLC

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Botsford Hospital

    Farmington, Michigan, 48336

  • Saint Agnes Hospital/Agnesian Cancer Center

    Fond du Lac, Wisconsin, 54935

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado, 80111

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Oncare Hawaii Inc-Kuakini

    Honolulu, Hawaii, 96817

  • OnCare Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • McFarland Clinic PC-Jefferson

    Jefferson, Iowa, 50129

  • Mercy Hospital-Joplin

    Joplin, Missouri, 64804

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • McFarland Clinic PC-Marshalltown

    Marshalltown, Iowa, 50158

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Contra Costa Regional Medical Center

    Martinez, California, 945553

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Saint Luke's Mountain States Tumor Institute - Meridian

    Meridian, Idaho, 83642

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Memorial Regional Cancer Center Day Road

    Mishawaka, Indiana, 46544

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Saint Luke's Mountain States Tumor Institute - Nampa

    Nampa, Idaho, 83686

  • Westfields Hospital/Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Christiana Gynecologic Oncology LLC

    Newark, Delaware, 19713

  • Delaware Clinical and Laboratory Physicians PA

    Newark, Delaware, 19713

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Regional Hematology and Oncology PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Oconomowoc Memorial Hospital-ProHealth Care Inc

    Oconomowoc, Illinois, 53066

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Rocky Mountain Cancer Centers-Parker

    Parker, Colorado, 80138

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Saint Mary Corwin Medical Center

    Pueblo, California, 81004

  • Rocky Mountain Cancer Centers - Pueblo

    Pueblo, Colorado, 81008

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Marshfield Clinic at James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • Lakeview Medical Center-Marshfield Clinic

    Rice Lake, Wisconsin, 54868

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin, 54868

  • OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Phelps County Regional Medical Center

    Rolla, Missouri, 65401

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Wisconsin, 48073

  • Nanticoke Memorial Hospital

    Sanford, Delaware, 19973

  • Saint Nicholas Hospital

    Sheboygan, Wisconsin, 53081

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Marshfield Clinic Cancer Care at Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48098

  • Saint Luke's Mountain States Tumor Institute-Twin Falls

    Twin Falls, Idaho, 83301

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Waukesha Memorial Hospital

    Waukesha, Illinois, 53188

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401

  • Methodist West Hospital

    West Des Moines, Iowa, 50266

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

  • Southeastern Medical Oncology Center-Wilson

    Wilson, North Carolina, 27893

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Providence Regional Cancer System-Yelm

    Yelm, Washington, 98597

Other trials in United States

About this study

Official title: Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial

This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.

Read the detailed description

Patients with cancer may receive chemotherapy that may cause nausea and vomiting. The purpose of this study is to determine if the use of olanzapine in combination with antiemetic therapy can significantly reduce nausea and vomiting in a large number of patients receiving chemotherapy. Patients are randomized to one of two treatment arms. Please see the "Arms and Intervention" sections for more detailed information. The primary objective is to compare the number of patients with no nausea for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) and overall periods (0-120 hours post-chemotherapy) for patients receiving HEC. The secondary objectives are:

  1. To compare the complete response (CR) (no emetic episodes and no use of rescue medication) in the acute, delayed and overall periods
  2. To compare the incidences of potential toxicities ascribed to olanzapine

Protocol treatment is to begin ≤ 14 days of registration. Patients will receive treatment on Days 1-4. Patients will be permitted to take rescue therapy of the treating investigator's choice for nausea and/or emesis/retching, based on clinical circumstances. After completing treatment, patients will be monitored for side effects.

Being tested
Olanzapine, Chemotherapy (cisplatin or cyclophosphamide and doxorubicin), Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant), Placebo
Medical subject headings
Hematologic Neoplasms, Nausea, Vomiting

What participants receive

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

  • OlanzapineDrug

    oral

  • Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)Drug

    oral or IV

  • Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)Drug

    oral or IV

  • PlaceboOther

    oral

Study groups in NCT02116530
Study groupRoleWhat they receive
Olanzapine + Chemotherapy + Antiemetic treatmentExperimentalPatients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs: * Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus * Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus * Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus * olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
Receives: Drug: Olanzapine; Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin); Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Placebo + Chemotherapy + Antiemetic treatmentActive comparatorPatients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs: * Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus * Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus * Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus * placebo
Receives: Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin); Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant); Other: Placebo

What is being measured

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

  1. Proportion of Patients With no Nausea

    No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.

    Measured: 0 to 120 hours after chemotherapy

Secondary outcomes (4)

  1. Median Nausea Scores

    Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).

    Measured: Baseline and Day 2 to Day 6 after chemotherapy

  2. Proportion of Patients With Complete Response

    Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.

    Measured: 0 to 120 hours after chemotherapy

  3. Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire

    Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).

    Measured: Baseline and day 2 to 6 days after chemotherapy

  4. Frequency of Rescue Medication

    Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.

    Measured: Day 2 to Day 6 after chemotherapy

Timeline

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

  1. First posted17 Apr 2014 (estimated)
  2. Study start20 Aug 2014
  3. Primary completion4 Apr 2015
  4. Study completion15 Jun 2017

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
Double blind
Who is masked
Participant, Investigator
Enrolment
401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02116530
Sponsor's protocol ID
A221301
Other IDs
NCI-2014-00446, U10CA031946
Status last verified
Jan 2025
First submitted
15 Apr 2014
Last updated
28 Jan 2025
Data monitoring committee
Yes

Publications

  • Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.

    PubMed 27410922

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