The California program for the investigational use of THC and marihuana in heterogeneous populations experiencing nausea and vomiting from anticancer therapy.
Published studies of delta 9-tetrahydrocannabinol (THC) and marihuana in the control of nausea and vomiting in cancer patients leave many unanswered questions about dosage, time of administration, technique of use, use in pediatric and geriatric patients, and continuous use for extended periods. Four separate protocols are described which will determine optimal dosage of oral THC in adults and children receiving cyclic chemotherapy and adults receiving chronic chemotherapy or radiotherapy, and the optimal dose for smoked marihuana. Side effects and efficacy will be assessed by chemotherapeutic agent or combination, type of cancer, age, sex, etc. How well THC is tolerated in the elderly and very ill are important questions to be answered. Research goals are combined with widespread therapeutic access of cancer patients to marihuana and THC. The problems of designing and sponsoring a very large-scale Phase III collaborative study involving community practitioners are outlined. The design stresses uniformity and simplicity to obtain compliance by the more than 200 investigators.
D000970:Antineoplastic Agents / Q000009:adverse effects*; D002140:California; D002188:Cannabis; D002214:Capsules; D002986:Clinical Trials as Topic; D013759:Dronabinol / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007880:Legislation, Drug; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D014481:United States; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
D000970:Antineoplastic Agents; D002214:Capsules; D013759:Dronabinol