Spots Global Cancer Trial Database for Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer

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Trial Identification

Brief Title: Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer

Official Title: Body Warming to Alter [Thermo] Regulation and the Microenvironment [B-WARM] Therapy: A Pilot Study

Study ID: NCT01896778

Conditions

Adult Liver Carcinoma

Malignant Head and Neck Neoplasm

Interventions

Hyperthermia Treatment

Laboratory Biomarker Analysis

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the feasibility and efficacy of 2 different Body Warming to Alter (Thermo) Regulation and the Microenvironment (B-WARM) regimens on altering tumor blood flow in patients with a variety of malignancies. SECONDARY OBJECTIVES: I. To determine if duration and thermal dose of B-WARM changes duration and extent of tumor blood flow changes in patients with a variety of malignancies. OUTLINE: Patients are randomized to 1of 2 arms. ARM I: Patients undergo B-WARM at 39 degrees Celsius (C) for 30 minutes. ARM II: Patients undergo B-WARM at 39 degrees C for 2 hours. After completion of study, patients are followed up at 30 days.