moderate Whole Body Hyperthermia (mWBH): Patients receiving 3-4 times mWBH
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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
Primary outcome measure(s)
change in the number of circulating tumor cells before therapy vs after therapy — Test therapy naive versus three months after the start of therapy 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.
Trial sites (1)
Facility
City
Region
Status
Klinik für Radioonkologie und Strahlentherapie
Berlin
Germany
Recruiting
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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