NCT01896778

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Liver Carcinoma
• Breast Carcinoma
• Colon Carcinoma
• Kidney Neoplasm
• Lung Carcinoma
• Malignant Head and Neck Neoplasm
• Malignant Neoplasm
• Melanoma
• Ovarian Neoplasm
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Hyperthermia Treatment	Undergo B-WARM
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-10-04
• Primary completion: 2018-02-23
• Completion: 2018-02-23
• First posted: 2013-07-11
• Last updated: 2022-07-25

Locations

1 site across 1 country: United States