Clinical trial · Interventional
UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213
NCT00064272CI-TRIAL-00024391IRB 2003-551completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea and Vomiting | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ginger extract | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive lower-dose oral ginger twice daily.
- interventionNames
- Drug: ginger extract
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive higher-dose oral ginger twice daily.
- interventionNames
- Drug: ginger extract
- type
- PLACEBO_COMPARATOR
- label
- Arm III
- description
- Patients receive oral placebo twice daily.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.