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A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer


OBJECTIVES:

- Compare the efficacy of 1 course of ginger vs placebo when administered in regimens
containing a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic and
dexamethasone (or the equivalent dose of IV methylprednisolone) in controlling
chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer.

- Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related
nausea in these patients.

- Determine the adverse effects of ginger when given 3 days before chemotherapy
administration in these patients.

- Determine the adverse effects of these antiemetic regimens during the 4 days after
chemotherapy.

- Compare the chemotherapy-related anticipatory nausea in patients treated with these
antiemetic regimens.

- Compare the quality of life during the 4 days after chemotherapy in patients treated
with these antiemetic regimens.

- Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients
after 2 courses of ginger vs placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to participating center. Patients are randomized to 1 of 4
treatment arms. Day 1 of each course is defined as the day of chemotherapy administration.

- Arm I: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy
courses 2 and 3.

- Arm II: Patients receive oral low-dose ginger and oral placebo twice daily on days -3
to 3 of chemotherapy courses 2 and 3.

- Arm III: Patients receive oral intermediate-dose ginger and oral placebo twice daily on
days -3 to 3 of chemotherapy courses 2 and 3.

- Arm IV: Patients receive oral high-dose ginger twice daily on days -3 to 3 of
chemotherapy courses 2 and 3.

Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a
5-hydroxytryptamine type-3 (5-HT3) receptor antagonist (ondansetron, granisetron,
tropisetron, and dolasetron mesylate) and dexamethasone (DM) (or the equivalent dose of IV
methylprednisolone (MePRDL)) on day 1 of courses 2 and 3.

Symptoms are assessed on day -3 to day 1 of courses 2 and 3 and on days 1-4 of courses 1-3.

Quality of life is assessed on day 4 of courses 1-3.

Nausea and vomiting are assessed 4 times daily on days 1-4 of courses 1-3.

PROJECTED ACCRUAL: A total of 706 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of cancer and be scheduled to receive at least 3 courses of chemotherapy

- Scheduled to receive chemotherapy with no planned interruption by radiotherapy
or surgery

- Chemotherapy courses must be separated by at least 2 weeks from day 1 to day 1
of next course

- Must have experienced nausea of any degree of severity after completion of the first
study-related course of chemotherapy

- Received a prior 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic
(ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone
(DM) given at any dose and by any route (or equivalent dose of IV methylprednisolone
(MePRDL)) on day 1 of course 1 of chemotherapy

- Scheduled to receive a 5-HT3 receptor antagonist antiemetic with DM (or equivalent
dose of IV MePRDL) on day 1 of courses 2 and 3 of chemotherapy

- No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count greater than 100,000/mm^3 at second course of chemotherapy

- No prior bleeding or blood coagulation disorder (e.g., thrombocytopenia or platelet
dysfunction)

Hepatic:

- No prior coagulation factor deficiency

Renal:

- Not specified

Cardiovascular:

- No prior vascular defect

Other:

- Able to understand English

- No concurrent or impending bowel obstruction

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent interferon therapy

Chemotherapy:

- See Disease Characteristics

- At least 6 months since other prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No concurrent warfarin or heparin for therapeutic anticoagulation

- Concurrent low-dose warfarin for maintenance of venous access allowed

- Concurrent rescue medications for control of symptoms caused by the cancer or its
treatment allowed as clinically indicated

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 2 (approximately 3-4 weeks on study drug)

Safety Issue:

No

Principal Investigator

Julie L. Ryan, PhD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

University of Rochester

Authority:

United States: Federal Government

Study ID:

CDR0000069401

NCT ID:

NCT00040742

Start Date:

March 2003

Completion Date:

April 2010

Related Keywords:

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified adult solid tumor, protocol specific
  • Nausea
  • Vomiting

Name

Location

MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - GreenvilleGreenville, South Carolina  29615
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
MBCCOP - Gulf CoastMobile, Alabama  36688
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306