Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
18 Years
N/A
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
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.
Inclusion 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
Type of Study:
Interventional
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
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000310163
NCT ID:
NCT00064272
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
Name | Location |
|---|---|
| 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 |
