A nontoxic system for 41.8 degrees C whole-body hyperthermia: results of a Phase I study using a radiant heat device.
A Phase I study of whole-body hyperthermia (WBH) (52 treatments/12 patients) was completed with no significant clinical toxicity. The study incorporated a thermal dose escalation scheme from 39.5 degrees-41.8 degrees C for up to 151 min. A radiant-heat device was utilized for producing WBH. During WBH, patients were sedated; endotracheal intubation was not required. No changes in cardiovascular, respiratory, hematological, or biochemical indices requiring clinical intervention occurred during the study. We conclude the radiant-heat device coupled with a defined pharmacological approach to WBH with appropriate patient screening yields a system for 41.8 degrees C WBH which is safe and efficient, is not labor intensive, and does not require general anesthesia and endotracheal intubation. This system is appropriate for a multimodality approach to various systemic cancers.
D000293:Adolescent; D000328:Adult; D000469:Alkaline Phosphatase / Q000032:analysis; D001219:Aspartate Aminotransferases / Q000097:blood; D001772:Blood Cell Count; D001786:Blood Glucose / Q000032:analysis; D003402:Creatine Kinase / Q000097:blood; D005069:Evaluation Studies as Topic; D005260:Female; D006321:Heart / Q000503:physiopathology; D006801:Humans; D006979:Hyperthermia, Induced / Q000009:adverse effects / Q000295:instrumentation*; D007770:L-Lactate Dehydrogenase / Q000097:blood; D008168:Lung / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000503:physiopathology / Q000628:therapy*
D001786:Blood Glucose; D007770:L-Lactate Dehydrogenase; D001219:Aspartate Aminotransferases; D003402:Creatine Kinase; D000469:Alkaline Phosphatase