UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

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