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

Study 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.

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Key things to know

Main goalBasic Science

This describes the study’s primary purpose.

What is being studiedHyperthermia Treatment and Laboratory Biomarker Analysis

The study team can explain what participation involves.

Who it may be forAdult Liver Carcinoma · Breast Carcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 25, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Roswell Park Cancer Institute

Study sponsor

Study overview

What this study is about

Purpose: Basic Science
Study type: Interventional
Phase: Not applicable
Sponsor: Roswell Park Cancer Institute
Interventions being studied: Procedure: Hyperthermia Treatment; Other: Laboratory Biomarker Analysis

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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
Patients may be enrolled on study but at least 21 days should elapse prior to date of B-WARM therapy
Patients should not have either CT scanning or B-WARM if they have a fever at the time
Fever should be worked up and treated as appropriate
Patients should be afebrile for 24 hours prior to scanning or B-WARM therapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 25, 2022. Always confirm current availability with the study team.

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