Overview
UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Michigan Cancer Center
University of Michigan Rogel Cancer CenterCollaborators:
National Cancer Institute (NCI)
National Center for Complementary and Integrative Health (NCCIH)
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