Those patients who qualify for inclusion in one of the thermal therapy (hyperthermia) clinical trials (see eligibility criteria) will receive a combination of fever-range whole body thermal therapy (FR-WB-TT) and chemotherapy, sometimes referred to as thermochemotherapy. The body is heated to a core temperature of 40oC using the Heckel HT2000M radiant heat device pictured above. An array of heat lamps within a soft-sided, reflective chamber directs infrared energy through the skin. Once the desired body temperature has been reached, the space blanket-like sides of the chamber are wrapped around the patient to maintain the temperature for 6 hours. The temperature can be adjusted as necessary by further use of the lamps for additional heating, or opening of the blankets to facilitate cooling. Patients are administered a light sedative to assist with relaxation and to remove any irritability resulting from the fever-like state. Care is given to maintain adquate hydration throughout the procedure.
The Food and Drug Administration (FDA) considers the process of combining WBH with chemotherapy an investigational procedure.
Such treatment can therefore only be administered according to a research protocol which has been approved by the UT-Houston Medical School's Committee for the
Protection of Human Subjects. Listed below are the currently approved protocols.
which together are accepting patients with the following cancer types:
breast
cervical
cholangioma
endometrial
gastric
head & neck
liver
lung
melanoma
ovarian
pancreas
The hyperthermia machine is classified by the FDA as a non-significant device. The chemotherapy drugs, which are given in a
specific sequence/schedule to maximize benefit when used with FR-WBH, are all FDA approved.