Clinical trial · Interventional
Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy
Multicenter, Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Activity of a Ginger (Zingiber Officinale) Food Supplement in the Management of Nausea in Patients Receiving Highly Emetogenic Treatments and Standard Anti-emetogenic Therapy.
NCT01887314CI-TRIAL-00020677completedN/AClinicalTrials.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)
The purpose of the study is verify the capability of a standardized Ginger (Zingiber officinale) extract to manage nausea in cancer patients receiving highly emetogenic treatments and standard anti-emetogenic therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Nausea | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standardized Ginger extract | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standardized Ginger extract soft gel capsules
- description
- Patients receive 2 soft gel capsules of Ginger extract, twice a day
- interventionNames
- Dietary Supplement: Standardized Ginger extract
- type
- PLACEBO_COMPARATOR
- label
- Placebo soft gel capsules
- description
- Patients receive 2 soft gel capsules of Placebo, twice a day
- interventionNames
- Dietary Supplement: Standardized Ginger extract
Primary outcomes (1)
- measure
- To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and Females aged \> 18 years. * Naïve to chemotherapy. * Patients planned to receive at least 2 cycles of highly emetogenic treatments with cisplatin in single dose \> 50 mg/m2 every 21 or 28 days. * Willing and able to understand and sign informed consent and complete the patient diary. Exclusion Criteria: * Presence of brain symptomatic metastases (in case of small, asymptomatic metastases and in absence of steroids treatment, the patient is eligible). * Scheduled to receive or having received in the past 4 weeks radiation treatment to brain, abdomen or pelvis. * Emesis or significant nausea within 24 hours before first chemotherapy cycle. * Known hypersensitivity reaction to Ginger or any components of the product. * Patients with coagulopathies causing potential increase risk of bleeding. * Patients on therapy with oral anticoagulants. * Planned surgery procedures in the period of the study or within 2 weeks after the study conclusion. * History of seizures. * Active use of cannabinoids. * Known current or past drug or alcohol abuse. * Use of other investigational drugs within 30 days before study entry or during the study. * Clinically significant findings on physical exam or presence of known clinically significant disease that would interfere with study evaluation
References
Publications (0)
Data not yet available
No reference posted for this study.