 |
|
Phase II Randomized Study of Ginger in Patients With Cancer and Chemotherapy-Induced Nausea and Vomiting
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Supportive care | Completed | 18 and over | CCUM-0201
NCT00064272 |
Special Category:
NCI Web site featured trial 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).
Entry 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-HT3 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] Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - See Disease Characteristics
- No prior chemotherapy regimens with multiple day doses
Endocrine therapy 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 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - No history of bleeding disorder
- No thrombocytopenia
Hepatic Renal 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
Expected Enrollment 180A total of 180 patients (60 per treatment arm) will be accrued for this study. Outcomes Primary Outcome(s)Most efficacious dose
Safety
Ability to distinguish between receiving placebo or study drug and variables involved (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-HT3 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.
Trial Contact Information
Trial Lead Organizations University of Michigan Cancer Center CCOP Research Base | | | | Suzanna Zick, MPH, ND, Protocol chair | | | |
Related Information Featured trial article
| Registry Information | | | Official Title | | Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting | | | Trial Start Date | | 2003-05-27 | | | Trial Completion Date | | 2007-05-31 | | | Registered in ClinicalTrials.gov | | NCT00064272 | | | Date Submitted to PDQ | | 2003-05-29 | | | Information Last Verified | | 2007-10-11 | | | NCI Grant/Contract Number | | CA46592, CA100612 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
|
