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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Collaborators: 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