Using moderate whole body hyperthermia to improve cancer treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of moderate whole-body hyperthermia (mWBH) on patients with advanced cancer. The study aims to evaluate how mWBH influences circulating tumor cells, tumor response, quality of life, fatigue, psychological well-being, immune response, and the tumor microenvironment. Patients will undergo mWBH in conjunction with their standard oncological treatments, and the outcomes will be measured three months after therapy. The trial seeks to clarify the mechanisms of action of mWBH and its potential benefits in oncology.

Why it matters

Who can join: the full rules

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

Where it's running

• Klinik für Radioonkologie und Strahlentherapie
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Sebastian Zschaeck, MD
• Email: sebastian.zschaeck@charite.de
• Phone: 030450650764

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.