|
Ginger Control of Chemotherapy Induced Nausea and Vomiting Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Ginger Control of Chemotherapy Induced Nausea and Vomiting conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Ginger Control of Chemotherapy Induced Nausea and Vomiting Clinical research trials and Ginger Control of Chemotherapy Induced Nausea and Vomiting healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Ginger Control of Chemotherapy Induced Nausea and Vomiting. Ginger Control of Chemotherapy Induced Nausea and Vomiting Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Ginger Control of Chemotherapy Induced Nausea and Vomiting clinical trial. Test subjects typically receive the most effective healthcare possible for their Ginger Control of Chemotherapy Induced Nausea and Vomiting condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Ginger Control of Chemotherapy Induced Nausea and Vomiting  Ginger Control of Chemotherapy Induced Nausea and Vomiting
Ginger Control of Chemotherapy Induced Nausea and Vomiting
For Condition: Vomiting,Nausea,Chemotherapy
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and severity of chemotherapy induced nausea and vomiting.
Details: 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. The study design is a double-blind, placebo-controlled, three-armed, randomized clinical trial to 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 48 hours after infusion in order to assess frequency and severity of nausea and vomiting. Baseline and 48 hour post chemotherapy labs will be used to assess safety profile of ginger.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Confirmed diagnosis of cancer and currently receiving chemo - Currently being treated with cisplatin, adriamycin, or a combination of these two chemo agents at any dose, or one of these agents + other chemo without concurrent radiotherapy or interferon treatment and experienced nausea and/or vomiting from this cycle - Scheduled to receive a 5-HT3 receptor antagonist antiemetic: ondansetron (Zofran®) granistron (Kytril®), tropisetron (Navoban®) or dolasetron mesylate (Anzemet®) - 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 of cisplatin, adriamycin, hexamethylmelamine, dacarbazine, nitrosoureas and streptozocin - No clinical evidence of current or impending bowel obstruction or symptomatic brain metastases - Pregnant or lactating - Patients taking coumadin, aspirin or heparin - Patients with a history of a bleeding disorder(s) or those experiencing thrombocytopenia - Must not currently be taking ginger or have taken ginger in the last month - Must not have allergy to ginger
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
SuzannaZick, Principal Investigator, University of Michigan
Community Clinic Oncology Program *Recruiting*
Grand Rapids, Michigan,
United States
Recruiting Nancy Gore 616-391-1230
Northern Indiana Cancer Research Consortium CCOP *Not yet recruiting*
South Bend, Indiana,
United States
Not yet recruiting Mary Wasielewski 800-284-7370
University of Michigan Cancer Center Complementary and Alternative Medicine Research Center *Recruiting*
Ann Arbor, Michigan, 48104
United States
Recruiting Amy Blume 734-998-0016
Our Lady of Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Jan Dutcher 718-920-1100
Community Clinic Oncology Program *Not yet recruiting*
San Juan, ,
Puerto Rico
Not yet recruiting Doris Cuadrado 787-758-7575
St. Joseph Mercy Hospital *Not yet recruiting*
Ann Arbor, Michigan, 48106
United States
Not yet recruiting Linda Beekman 734-712-5947
Additional Information:
Study ID Numbers: R21AT001735-01;
Study Start Date: November 2003
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065221
Other Chemotherapy Studies:
1. Ginger Control of Chemotherapy Induced Nausea and Vomiting
2. A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas
Related Studies:
Other Chemotherapy Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Ginger Control of Chemotherapy Induced Nausea and Vomiting
|
|
|
|
|
|
|
|
