Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer (NCT01896778) | Clinical Trial Compass
CompletedNot Applicable
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
United States9 participantsStarted 2013-10-04
Plain-language summary
This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a variety of malignancies (i.e., melanoma, sarcoma, colon, head and neck, renal, breast, lung, ovary, liver)
* Patients must have measurable disease (1.0 cm or greater) by computed tomography (CT) scan
* Have an estimated glomerular filtration rate (eGFR) (using the Cockcroft-Gault equation) of more than 60 mL/min
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* History of prior myocardial infarction or arrhythmia
* History of any condition deemed by the principal investigator to be a contraindication to B-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc)
* All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc)
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive B-WARM
* Received an investigational agent within 30 days prior to enrollment
* Received any systemic therapy within 21 days prior to planned B-WARM therapy
* Patie…
What they're measuring
1
Changes in tumor vascular (blood flow, blood volume)