UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (IRB 2003-551)

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00064272
First received: July 8, 2003
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.


Condition Intervention Phase
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: ginger extract
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Most efficacious dose
  • Safety
  • Ability to distinguish between receiving placebo or study drug and variables involved (e.g., taste, smell, or decrease in nausea and vomiting)

Estimated Enrollment: 180
Study Start Date: May 2003
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive lower-dose oral ginger twice daily.
Dietary Supplement: ginger extract
Given orally
Experimental: Arm II
Patients receive higher-dose oral ginger twice daily.
Dietary Supplement: ginger extract
Given orally
Placebo Comparator: Arm III
Patients receive oral placebo twice daily.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.

Secondary

  • Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.
  • Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist).

  • Arm I: Patients receive lower-dose oral ginger twice daily.
  • Arm II: Patients receive higher-dose oral ginger twice daily.
  • Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of cancer
  • Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute)

    • Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only)
  • Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria:

    • Agent is the same that is scheduled for the next round of chemotherapy
    • Experienced nausea and/or vomiting of any severity (delayed or acute)
  • Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy
  • No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • No history of bleeding disorder
  • No thrombocytopenia

Hepatic

  • Not specified

Renal

  • Not specified

Gastrointestinal

  • Able to swallow capsules
  • No gastric ulcer
  • No clinical evidence of current or impending bowel obstruction

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to understand English
  • Able to complete study questionnaires
  • No allergy to ginger

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy regimens with multiple day doses

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas:

    • Total body irradiation
    • Hemi-body
    • Upper abdomen
    • Abdominal-pelvic mantle
    • Cranium (radiosurgery)
    • Craniospinal radiotherapy

Surgery

  • Not specified

Other

  • More than 1 week since prior ginger (teas, capsules, tinctures)
  • No other concurrent ginger (teas, capsules, tinctures)

    • Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed
  • No concurrent therapeutic-doses of warfarin, aspirin, or heparin

    • Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064272

Locations
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
University of Michigan Cancer Center CCOP Research Base
Ann Arbor, Michigan, United States, 48109-0725
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
United States, New York
MBCCOP - Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
Puerto Rico
MBCCOP - San Juan
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Study Chair: Suzanna Zick, MPH, ND University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00064272     History of Changes
Other Study ID Numbers: CDR0000310163, P30CA046592, CCUM-0201
Study First Received: July 8, 2003
Last Updated: March 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan Cancer Center:
nausea and vomiting
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014