RecruitingPhase 2NCT05821166
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
Sponsor
Charite University, Berlin, Germany
Enrollment
80 participants
Start Date
Feb 1, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria8
- 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:
- 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.
- Patients with metastatic or inoperable pancreatic cancer, who are planning first-line chemotherapy with FOLFIRINOX is.
- 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.
- Patients with metastatic high-grade sarcoma for whom metastasis-directed ablative therapy methods are not possible and palliative first-line therapy with doxorubicin.
- 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.
- 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 Criteria8
- 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
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Interventions
DEVICEmoderate Whole Body Hyperthermia (mWBH)
Patients receiving 3-4 times mWBH
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05821166
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