Clinical trial · Interventional
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
NCT01896778CI-TRIAL-00059869completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Liver Carcinoma | Adult Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colon Carcinoma | Colon Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Kidney Neoplasm | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Head and Neck Neoplasm | Malignant Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasm | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermia Treatment | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (B-WARM for 30 minutes)
- description
- Patients undergo B-WARM at 39 degrees C for 30 minutes.
- interventionNames
- Procedure: Hyperthermia Treatment
- Other: Laboratory Biomarker Analysis
- type
- EXPERIMENTAL
- label
- Arm II (B-WARM for 2 hours)
- description
- Patients undergo B-WARM at 39 degrees C for 2 hours.
- interventionNames
- Procedure: Hyperthermia Treatment
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Changes in tumor vascular (blood flow, blood volume)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.