Potential of Moderate Whole Body Hyperthermia to Enhance Response

Recruiting now · Phase 2

Conditions studied: Oncology

In brief

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

Key facts

Study ID

NCT05821166

Run by

Charite University, Berlin, Germany

People needed

80

Starts

2023-02-01

Expected to finish

2027-12-01

Last updated by the study team

2023-04-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Klinik für Radioonkologie und Strahlentherapie — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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