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Home > "G" Clinical Trials Conditions > Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer  Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
For Condition: nausea and vomiting,unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Rochester , National Cancer Institute (NCI)
Synopsis: RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy. PURPOSE: Randomizedphase II/III trial to determine the effectiveness of antiemetic drugs with or without ginger in treating nausea in patients who are receiving chemotherapy for cancer.
Details: OBJECTIVES: - Compare the efficacy of 1 course of ginger vs placebo when administered in regimens containing a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic and dexamethasone (or the equivalent dose of IV methylprednisolone) in controlling chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer. - Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related nausea in these patients. - Determine the adverse effects of ginger when given 3 days before chemotherapy administration in these patients. - Determine the adverse effects of these antiemetic regimens during chemotherapy course 3 in these patients. - Compare the chemotherapy-related anticipatory nausea in patients treated with these antiemetic regimens. - Compare the quality of life during the 4 days after chemotherapy in patients treated with these antiemetic regimens. - Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients after 2 courses of ginger vs placebo. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 4 treatment arms. Day 1 of each course is defined as the day of chemotherapy administration. - Arm I: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. - Arm II: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. - Arm III: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. - Arm IV: Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3. Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a 5-hydroxytryptamine type-3 (5-HT3) receptor antagonist (ondansetron, granisetron, tropisetron, and dolasetron mesylate) and dexamethasone (DM) (or the equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of courses 2 and 3. Symptoms are assessed on day -3 to day 1 of courses 2 and 3 and on days 1-4 of courses 1-3. Quality of life is assessed on day 4 of courses 1-3. Nausea and vomiting are assessed 4 times daily on days 1-4 of courses 1-3. PROJECTED ACCRUAL: A total of 706 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of cancer for which no more than 1 of at least 3 of the projected courses of chemotherapy has been or is currently being administered - Scheduled to receive chemotherapy with no planned interruption by radiotherapy or surgery - Chemotherapy courses must be separated by at least 2 weeks from day 1 to day 1 of next course - Must have experienced nausea of any degree of severity after completion of the first study-related course of chemotherapy - Received a prior 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone (DM) given at any dose and by any route (or equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of course 1 of chemotherapy - Scheduled to receive a 5-HT3 receptor antagonist antiemetic with DM (or equivalent dose of IV MePRDL) on day 1 of courses 2 and 3 of chemotherapy - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Platelet count greater than 100,000/mm^3 at second course of chemotherapy - No prior bleeding or blood coagulation disorder (e.g., thrombocytopenia or platelet dysfunction) Hepatic: - No prior coagulation factor deficiency Renal: - Not specified Cardiovascular: - No prior vascular defect Other: - Able to understand English - No concurrent or impending bowel obstruction PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent interferon therapy Chemotherapy: - See Disease Characteristics - At least 6 months since other prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - No concurrent warfarin or heparin for therapeutic anticoagulation - Concurrent low-dose warfarin for maintenance of venous access allowed - Concurrent rescue medications for control of symptoms caused by the cancer or its treatment allowed as clinically indicated
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JaneHickok, Study Chair, James P. Wilmot Cancer Center
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Porter Adventist Hospital *Recruiting*
Denver, Colorado, 80210
United States
Recruiting David Trevarthen 303-788-8675
Boulder Community Hospital *Recruiting*
Boulder, Colorado, 80301-9019
United States
Recruiting John Fleagle 303-440-2399
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
Rocky Mountain Cancer Centers *Recruiting*
Thornton, Colorado, 80260
United States
Recruiting Alvin Otsuka 303-386-7622
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Medical Center of Aurora - South Campus *Recruiting*
Aurora, Colorado, 80012-0000
United States
Recruiting Sami Diab 303-418-7600
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
Presbyterian-St Luke's Medical Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Robert Jotte 303-388-4876
Longmont United Hospital *Recruiting*
Longmont, Colorado, 80501
United States
Recruiting Robert Fisher 303-485-4132
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
Swedish Medical Center *Recruiting*
Englewood, Colorado, 80110
United States
Recruiting Marshall Davis 303-788-5860
Penrose Cancer Center *Recruiting*
Colorado Springs, Colorado, 80933
United States
Recruiting Robert Sayre 719-577-2555
Sky Ridge Medical Center *Recruiting*
Lone Tree, Colorado, 80124
United States
Recruiting Dennis Carter 720-225-4211
St. Mary-Corwin Regional Medical Center *Recruiting*
Pueblo, Colorado, 81004
United States
Recruiting Marlow Sloan 719-560-6000
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Rocky Mountain Cancer Centers - Rose *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Scot Sedlacek 303-321-0302
St. Joseph Hospital *Recruiting*
Denver, Colorado, 80218-1191
United States
Recruiting Michael McLaughlin 303-861-3302
Additional Information:
Study ID Numbers: CDR0000069401; NCI-P02-0223,URCC-U1902,NCI-5857,URCC-0114
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040742
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
2. Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
3. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
4. Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
5. Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Wisconsin Clinical Trials
Other Marshfield Clinical Trials
Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
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