Phase 3
N=744
Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00040742 ↗Enrolled (actual)
744
Serious AEs
0.1%
Results posted
Mar 2015
Primary outcome: Primary: Change From Baseline of Peak Acute Nausea — 0.03; -0.56; -0.44; -0.15 units on a scale — p=.017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ginger (Dietary_supplement); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gary Morrow
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of Peak Acute Nausea |
0.03; -0.56; -0.44; -0.15 | .017 sig |
| SECONDARY Average Nausea Severity |
0.03; -0.44; -0.34; -0.05 | 0.046 sig |
Summary
RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy.
PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cancer and be scheduled to receive at least 3 courses of chemotherapy
- Scheduled to receive chemotherapy with no planned interruption by radiotherapy or surgery
- Chemotherapy courses must be separated by at least 2 weeks from day 1 to day 1 of next course
- Must have experienced nausea of any degree of severity after completion of the first study-related course of chemotherapy
- Received a prior 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone (DM) given at any dose and by any route (or equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of course 1 of chemotherapy
- Scheduled to receive a 5-HT3 receptor antagonist antiemetic with DM (or equivalent dose of IV MePRDL) on day 1 of courses 2 and 3 of chemotherapy
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count greater than 100, 000/mm^3 at second course of chemotherapy
- No prior bleeding or blood coagulation disorder (e.g., thrombocytopenia or platelet dysfunction)
Hepatic:
- No prior coagulation factor deficiency
Renal:
- Not specified
Cardiovascular:
- No prior vascular defect
Other:
- Able to understand English
- No concurrent or impending bowel obstruction
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent interferon therapy
Chemotherapy:
- See Disease Characteristics
- At least 6 months since other prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No concurrent warfarin or heparin for therapeutic anticoagulation
- Concurrent low-dose warfarin for maintenance of venous access allowed
- Concurrent rescue medications for control of symptoms caused by the cancer or its treatment allowed as clinically indicated
Data sourced from ClinicalTrials.gov (NCT00040742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.