Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Efficacy Study of Oral Dronabinol Alone and in Combination With Ondansetron Versus Ondansetron Alone in Subjects With Delayed Chemotherapy-Induced Nausea and Vomiting

Conditions
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Chemotherapy Induced Nausea and Vomiting

Intervention / Treatment
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* Drug: dronabinol
* Drug: ondansetron
* Drug: dronabinol/ondansetron
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: dronabinol<br>* 10 - 20 mg<br>|
| Active Comparator: 2<br> | Drug: ondansetron<br>* 8 - 16 mg<br>|
| Other: 3<br> | Drug: dronabinol/ondansetron<br>* 10 - 20 mg/8 - 16 mg<br>|
| Placebo Comparator: 4<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CINV, chemotherapy, nausea, vomiting, retching