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Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00040742
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : March 10, 2015
Last Update Posted : November 9, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester

Tracking Information
First Submitted Date  ICMJE July 8, 2002
First Posted Date  ICMJE January 27, 2003
Results First Submitted Date  ICMJE July 10, 2014
Results First Posted Date  ICMJE March 10, 2015
Last Update Posted Date November 9, 2015
Study Start Date  ICMJE March 2003
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
Change From Baseline of Peak Acute Nausea [ Time Frame: 3-4 days on study drug ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
Average Nausea Severity [ Time Frame: 3-4 days on study drug ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Official Title  ICMJE A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Nausea
  • Vomiting
Intervention  ICMJE
  • Dietary Supplement: ginger
    Given orally
  • Other: placebo
    Given orally
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
    Intervention: Other: placebo
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: ginger
    • Other: placebo
  • Experimental: 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.
    Interventions:
    • Dietary Supplement: ginger
    • Other: placebo
  • Experimental: 1.5g ginger
    Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
    Intervention: Dietary Supplement: ginger
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2015)
745
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00040742
Other Study ID Numbers  ICMJE CDR0000069401
U10CA037420 ( U.S. NIH Grant/Contract )
URCC U1902 ( Other Identifier: University of Rochester CCOP Research Base )
URCC-0114 ( Other Identifier: NCI DCP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Morrow, University of Rochester
Study Sponsor  ICMJE Gary Morrow
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Julie L. Ryan, PhD, MPH University of Rochester
PRS Account University of Rochester
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP