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

Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Nausea and Vomiting
• Intervention / Treatment: Other: placebo; Drug: ginger extract

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • MBCCOP - San Juan
• United States
  • Indiana
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0942
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48109-0725
      • University of Michigan Cancer Center CCOP Research Base
    • Grand Rapids, Michigan, United States, 49503
      • CCOP - Grand Rapids
  • New York
    • Bronx, New York, United States, 10466
      • MBCCOP - Our Lady of Mercy Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Patients receive lower-dose oral ginger twice daily.	Drug: ginger extract; Given orally
Experimental: Arm II; Patients receive higher-dose oral ginger twice daily.	Drug: ginger extract; Given orally
Placebo Comparator: Arm III; Patients receive oral placebo twice daily.	Other: placebo; Given orally

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Cancer Institute (NCI); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Study Chair: Suzanna Zick, MPH, ND, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: July 8, 2003
• First Submitted That Met QC Criteria: July 8, 2003
• First Posted (Estimate): July 9, 2003

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 20, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; nausea and vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: CDR0000310163; P30CA046592 (U.S. NIH Grant/Contract); CCUM-0201