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

Phase 2
18 Years
Not Enrolling
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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



- 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


- 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

Inclusion Criteria


- 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



- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified


- No history of bleeding disorder

- No thrombocytopenia


- Not specified


- Not specified


- Able to swallow capsules

- No gastric ulcer

- No clinical evidence of current or impending bowel obstruction


- 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


Biologic therapy

- Not specified


- See Disease Characteristics

- No prior chemotherapy regimens with multiple day doses

Endocrine therapy

- Not specified


- 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


- Not specified


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Most efficacious dose

Principal Investigator

Suzanna Zick, MPH, ND

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified adult solid tumor, protocol specific
  • Nausea
  • Vomiting



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
CCOP - Grand Rapids Grand Rapids, Michigan  49503
University of Michigan Cancer Center CCOP Research Base Ann Arbor, Michigan  48109-0725
MBCCOP - Our Lady of Mercy Cancer Center Bronx, New York  10466