s_meksvanh Posted August 30, 2003 Share Posted August 30, 2003 CLINICAL TRIAL Phase: Phase 1 Status: Recruiting PURPOSE: This study will evaluate patient response to new adjuvant treatment. ELIGIBILITY CRITERIA Open to: All NSCLC and SCLC patients - irrespective of stage, cell type, size of tumor, or metastasis. Prior Treatment: All patients having undergone surgery, chemotherapy, radiation treatment, gene therapy, vaccines, or any other forms of treatment are eligible to participate. Selected patients will continue treatment as prescribed but will also be given this new adjuvant treatment. This is a Double Blind Study: In addition to standard treatment, Cohort 1 will be given one (1) pint of Hagen-Daas ice cream (flavor of your own choosing) to eat per day. They will also be subjected to endure rest and relaxation at a resort of their own choosing in the continental U.S. They will be required to subject themselves to daily dose of massages, whirlpools, and saunas. After 3 months, patient response and toxicity levels will be compared to standard treatment. If new treatment compares favorably, treatment protocol will be repeated six more times over the course of 18 months. In addition to standard treatment, Cohort 2 will be subjected to spend days by the seaside under extreme conditions (sun, surf, sand) and be served cold foo-foo drinks with little umbrellas. They will engage in full contact origami and be subjected to intense episodes of laughter. They will be required to get up at the break of day and endure full body massages while being fanned by superb looking creatures of their own choosing. After 3 months, patient response and toxicity levels will be compared to standard treatment. As with Cohort 1, if new treatment compares favorably, treatment protocol will be repeated six more times over the course of 18 months. CONTRAINDICATIONS TO TREATMENT: Negative attitude of any kind will not be tolerated. Patients presenting this type of profile will be subjected to hours of watching Johnny Carson, David Letterman or Jay Leno. They will be forced to eat their dessert before their dinner and they will be subjected to unmerciful tickling. Quote Link to comment Share on other sites More sharing options...
mhutch1366 Posted September 15, 2003 Share Posted September 15, 2003 This can't be Phase I; Phase I is for toxicity. Nobody has truly died laughing, or from an overdose of Haagen-Daz that I know of. This should be a phase II with large number recruitment. Multi-center, open enrollment. Not sure about the placebo arm. May be deemed unnecessary, and subject to compassionate exclusion. Sounds like a good idea. Quote Link to comment Share on other sites More sharing options...
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