Ginger Control of Chemotherapy Induced Nausea and Vomiting

Nausea Clinical Trial

Official title:

Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065221
• Other study ID #: R21AT001735-01
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2003
• Last updated: January 24, 2008
• Start date: June 2003
• Est. completion date: January 2007

Study information

• Verified date: January 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy
• Nausea
• Vomiting

Intervention

Drug:
• Ginger

Locations

Country	Name	City	State
Puerto Rico	Community Clinic Oncology Program	San Juan
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	University of Michigan Cancer Center Complementary and Alternative Medicine Research Center	Ann Arbor	Michigan
United States	Our Lady of Mercy Medical Center, Comprehensive Cancer Center	Bronx	New York
United States	Community Clinic Oncology Program	Grand Rapids	Michigan
United States	Northern Indiana Cancer Research Consortium CCOP	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Countries where clinical trial is conducted

United States,  Puerto Rico,