Ginger Control of Chemotherapy Induced Nausea and Vomiting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and severity of chemotherapy induced nausea and vomiting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

NCT00064272

Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE2

Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

NCT00040742

Nausea Vomiting

COMPLETED PHASE2/PHASE3

Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting

NCT02390648

Chemotherapy-induced Nausea and Vomiting

COMPLETED PHASE2

A Study to Assess the Anti-Emetic Efficacy of Ginger in Children and Adolescents Receiving Chemotherapy

NCT00940368

Nausea Vomiting

UNKNOWN PHASE3

Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies

NCT06150469

Hematological Malignancies

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chemotherapy induced nausea and vomiting significantly reduces patients' quality of life, increases fatigue, anxiety, and increases costs of health care delivery. Ginger (Zingiber officinalis) is already used in traditional folk medicine to treat nausea and vomiting in various populations. Ginger's ability to block 5-HT3 receptors and its free-radical scavenging in the intestines suggest that it may be beneficial for reducing both the prevalence and severity of chemotherapy induced nausea and vomiting. Despite ginger's possible benefits in reducing the prevalence and severity of chemotherapy induced nausea and vomiting, no dosing and/or safety studies have been performed.

This study will assess the efficacy and safety of two dose levels (1000 mg, or 2000 mg, orally/day) of Zingiber officinalis extract (standardized for 5% gingerols) in patients undergoing chemotherapy (cisplastin or adriamycin) who have experienced at least one episode of chemotherapy induced nausea and vomiting despite optimal conventional medical therapy. The primary aim of the study is to determine the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of acute nausea and vomiting. Secondary aims of the study include (1) determination of the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of delayed nausea and vomiting; (2) assessment of the safety of different doses of oral powdered ginger root in patients receiving chemotherapy; and (3) determination if study participants can discern if they are receiving placebo or ginger. Participants receiving either adriamycin or cisplatin for cancer related treatment will be randomized to receive one of two doses of powdered ginger or placebo immediately prior to chemotherapy infusion. Participants will be followed for 72 hours after infusion in order to assess frequency and severity of nausea and vomiting. Baseline and 72 hour post chemotherapy labs will be used to assess safety profile of ginger.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nausea Vomiting Chemotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ginger

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed diagnosis of cancer and currently receiving chemotherapy
* Currently being treated with any chemotherapeutic agent at any dose, and have experienced nausea and/or vomiting from a previous round of chemothearpy
* Scheduled to receive a 5-HT3 receptor antagonist antiemetic: ondansetron (Zofran®) granistron (Kytril®), tropisetron (Navoban®) or dolasetron mesylate (Anzemet®), palanosetron (Alozi) and/or the NK1 antagonist aprepitant (Emend)
* Must be able to swallow capsules
* Must be able to understand English or Spanish, complete questionnaires in English or Spanish
* Women of childbearing age to use appropriate birth control

Exclusion Criteria

* Chemotherapy regimens with multiple-day doses
* Clinical evidence of current or impending bowel obstruction or symptomatic brain metastases

* Concurrent radiotherapy that is classified as high or intermediate risk of causing nausea and vomiting; total body irradiation, hemi-body, upper abdomen, abdominal-pelvic mantle, cranium, craniospinal irradiation
* Pregnant or lactating
* Patients with a history of a bleeding disorder(s) or those experiencing thrombocytopenia
* Currently be taking ginger or have taken ginger in the last month
* Have an allergy to ginger

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No