Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Gary Morrow
With
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 the 4 days after chemotherapy. * 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. * Placebo: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. * 0.5g Ginger: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. * 1.0g Ginger: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3. * 1.5g Ginger: 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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
