Clinical trial · Interventional
Potential of Moderate Whole Body Hyperthermia to Enhance Response
Moderate Whole-body Hyperthermia in Tumor Patients: Influence on Circulating Tumor Cells, Tumor Response, Quality of Life, Fatigue, Psyche, Immune Response and Tumor Microenvironment
NCT05821166CI-TRIAL-00065833POWERrecruitingPhase 2ClinicalTrials.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)
Using moderate whole-body hyperthermia (mWBH) in tumor patients to see the influence on circulating tumor cells, tumor response, quality of life, fatigue, psyche, immune response and tumor microenvironment
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| moderate Whole Body Hyperthermia (mWBH) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mWBH
- description
- patients receiving moderate Whole Body Hyperthermia
- interventionNames
- Device: moderate Whole Body Hyperthermia (mWBH)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients do not receive moderate Whole Body Hyperthermia
Primary outcomes (1)
- measure
- change in the number of circulating tumor cells before therapy vs after therapy
- timeFrame
- Test therapy naive versus three months after the start of therapy
- description
- ANCOVA is used as the statistical methodology. The change in the number of circulating tumor cells three months after the start of therapy is the dependent variable, the group (intervention or control) and the number of circulating tumor cells as well as the tumor entity (6 groups) are independent variables. Case number estimation: So far there are no studies that have examined this outcome. We assume that the intervention effect is moderate and that an effect size of 0.6 to 0.7 can be achieved. If 36 patients per arm are included in the study, an effect size (Cohen's d) of 0.67 or greater at a two-sided significance level of α=0.05 with a power of 80% can be demonstrated using the t-test for independent samples.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * The general condition of the patients must be sufficient for multimodal treatment (corresponding to WHO status 0-2) * Tumordisease in a palliative setting of the following 6 groups: 1. Malignant melanoma, treatment-naive stage IV with multiple metastases and missing BRAF-V600 mutation. With indication for initiation of immunotherapy using PD-1 and CTLA-4 antibody therapy. 2. Patients with metastatic or inoperable pancreatic cancer, who are planning first-line chemotherapy with FOLFIRINOX is. 3. Patients with an indication for palliative radiation therapy extracranial, tumor manifestation with a prescribed radiation dose of 30 to 36 Gy due to hormone receptor-positive carcinoma of the breast, patients must have at least one additional (marker) lesion not treated with radiation. 4. Patients with metastatic high-grade sarcoma for whom metastasis-directed ablative therapy methods are not possible and palliative first-line therapy with doxorubicin. 5. Patients with metastatic or loco-regionally recurrent HPV-associated squamous cell carcinoma (of the head and neck region, cervix, anus or vulva) for whom local therapies are not possible and for whom palliative first-line therapy containing platinum is planned. 6. Patients with metastatic, castration-resistant prostate cancer, with progressive disease after exceeding the recommended therapy options for which a therapy attempt with lutetium-177-PSMA was indicated. Exclusion Criteria: * Presence of contraindications to simultaneous chemotherapy or whole-body hyperthermia * Serious or active comorbidities that could interfere with treatment or understanding of the nature and content of the study, for example: * Chronic inflammatory bowel disease * Acute infections * Serious cardiovascular or pulmonary comorbidities * Mental illnesses, showing the proper Study participation or recording the nature of the study to make impossible * Presence of cerebral metastasis * Diabetes mellitus with risk of end-organ damage
References
Publications (0)
Data not yet available
No reference posted for this study.