Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040742
• Other study ID #: CDR0000069401
• Secondary ID: U10CA037420URCC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 8, 2002
• Last updated: October 13, 2015
• Start date: March 2003
• Est. completion date: December 2011

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy.

PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer.

Description:

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.

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

• 0.5g Ginger: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

• 1.0g Ginger: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

• 1.5g Ginger: 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 745
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Dietary Supplement:
• ginger
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	CCOP - Greenville	Greenville	South Carolina
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	CCOP - North Shore University Hospital	Manhassett	New York
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Metro-Minnesota	St. Louis Park	Minnesota
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline of Peak Acute Nausea	Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings.; Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure.; Negative values for this outcome are favorable.	3-4 days on study drug	No
Secondary	Average Nausea Severity	Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings.; Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure.; Negative values for this outcome are favorable.	3-4 days on study drug	No