Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Supportive care	Closed	18 and over	NCI	URCC-U1902 URCC-0114, NCI-5857, NCI-P02-0223, NCT00040742

Objectives

1. 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.
2. Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related nausea in these patients.
3. Determine the adverse effects of ginger when given 3 days before chemotherapy administration in these patients.
4. Determine the adverse effects of these antiemetic regimens during the 4 days after chemotherapy.
5. Compare the chemotherapy-related anticipatory nausea in patients treated with these antiemetic regimens.
6. Compare the quality of life during the 4 days after chemotherapy in patients treated with these antiemetic regimens.
7. Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients after 2 courses of ginger vs placebo.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 100,000/mm³ 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

Expected Enrollment

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

Outcomes

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

Effective dose of ginger for chemotherapy-related nausea as determined by Nausea and Vomiting Diary and Symptom Inventory at course 2 (approximately 3-4 weeks on study drug)
Adverse effects of ginger as determined by Symptom Inventory, Platelet Count Form, and AE Report at course 3
Efficacy of ginger on chemotherapy-related anticipatory nausea as determined by Nausea and Vomiting Diary and Symptom Inventory at course 3 (approximately 6-8 weeks on study drug)
Quality of life by Functional Assessment Cancer Therapy-General at course 3 (approximately 6-8 weeks on study drug)
Efficacy of ginger on chemotherapy-related nausea as determined by Nausea and Vomiting Diary at course 3 (approximately 6-8 weeks on study drug)

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.

Trial Contact Information

Trial Lead Organizations

University of Rochester Cancer Center CCOP Research Base

Julie Ryan, PhD, MPH, Protocol chair		Ph: 585-275-5830

Registry Information
Official Title		A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer
Trial Start Date		2003-03-26
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00040742
Date Submitted to PDQ		2002-04-29
Information Last Verified		2008-12-07
NCI Grant/Contract Number		CA037420

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