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)

Klinik für Radioonkologie und Strahlentherapie

Berlin, Germany

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NCT05821166


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