Overview

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