Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Interventions
- Registration Number
- NCT00642512
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
-
Histological evidence of non-CNS malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow.
-
Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:
- a moderate-to-high emetogenic regimen, or
- oxaliplatin at doses employed for treatment of colon cancer, or
- the combination of AC [AdriamycinÒ (60 mg/m2) with cyclophosphamide (600 mg/m2)] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer.
- Chemotherapy agents falling into the low (Level 1), moderate-to-low (Level 2), moderate (Level 3) unless used in combination with a Level 4 chemotherapy agent on Day 1 of the study.
- Chemotherapy agents falling into the high (Level 5) classification during study.
- Any combination of chemotherapy agents that does not fall into the moderate-to-high (Level 4) classification
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 dronabinol/ondansetron - 4 placebo - 1 dronabinol - 2 ondansetron -
- Primary Outcome Measures
Name Time Method Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication. 5 days
- Secondary Outcome Measures
Name Time Method Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication) 5 days Presence or absence of nausea 5 days Episodes of vomiting and/or retching 5 days Duration of nausea and vomiting and/or retching 5 days
Related Research Topics
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Trial Locations
- Locations (43)
Site 943
🇺🇸Rancho Mirage, California, United States
Site 922
🇺🇸Marietta, Georgia, United States
Site 905
🇺🇸Southfield, Michigan, United States
Site 904
🇺🇸Missoula, Montana, United States
Site 934
🇺🇸Oklahoma City, Oklahoma, United States
Site 917
🇺🇸Chattanooga, Tennessee, United States
Site 939
🇺🇸Chattanooga, Tennessee, United States
Site 949
🇺🇸Valhalla, New York, United States
Site 958
🇺🇸St. Louis, Missouri, United States
Site 924
🇺🇸Hollywood, Florida, United States
Site 937
🇺🇸Greenwood, Mississippi, United States
Site 950
🇺🇸Anaheim, California, United States
Site 970
🇺🇸Tucson, Arizona, United States
Site 932
🇺🇸Boynton Beach, Florida, United States
Site 940
🇺🇸Lakeland, Florida, United States
Site 909
🇺🇸Los Angeles, California, United States
Site 921
🇺🇸New Port Richey, Florida, United States
Site 914
🇺🇸Orland Park, Illinois, United States
Site 948
🇺🇸Brooklyn, New York, United States
Site 946
🇺🇸Springfield, Illinois, United States
Site 929
🇺🇸New Port Richey, Florida, United States
Site 956
🇺🇸Terre Haute, Indiana, United States
Site 928
🇺🇸Harvey, Illinois, United States
Site 916
🇺🇸Fergus Falls, Minnesota, United States
Site 926
🇺🇸Skokie, Illinois, United States
Site 920
🇺🇸Voorhees, New Jersey, United States
Site 944
🇺🇸Columbus, Ohio, United States
Site 915
🇺🇸Texarkana, Texas, United States
Site 913
🇺🇸Greenbrae, California, United States
Site 925
🇺🇸Fountain Valley, California, United States
Site 908
🇺🇸Pomona, California, United States
Site 933
🇺🇸Ormond Beach, Florida, United States
Site 910
🇺🇸Bronx, New York, United States
Site 953
🇺🇸Brooklyn, New York, United States
Site 931
🇺🇸Philadelphia, Pennsylvania, United States
Site 906
🇺🇸Pittsburgh, Pennsylvania, United States
Site 947
🇺🇸Wilmington, North Carolina, United States
Site 923
🇺🇸N. Charleston, South Carolina, United States
Site 902
🇺🇸Bismarck, North Dakota, United States
Site 942
🇺🇸Fargo, North Dakota, United States
Site 951
🇺🇸Arlington, Virginia, United States
Site 918
🇺🇸Charleston, South Carolina, United States
Site 919
🇺🇸Little Silver, New Jersey, United States