Actively Recruiting

Phase 2
Age: 18Years - 100Years
All Genders
NCT05821166

Potential of Moderate Whole Body Hyperthermia to Enhance Response

Led by Charite University, Berlin, Germany · Updated on 2023-04-20

80

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Potential of Moderate Whole Body Hyperthermia to Enhance Response

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have a general health status suitable for multimodal treatment (WHO status 0-2)
  • Diagnosis of one of the following cancers in a palliative setting: malignant melanoma stage IV without BRAF-V600 mutation planned for PD-1 and CTLA-4 antibody immunotherapy
  • Metastatic or inoperable pancreatic cancer planned for first-line chemotherapy with FOLFIRINOX
  • Hormone receptor-positive breast cancer planned for palliative radiation therapy with at least one additional untreated tumor lesion
  • Metastatic high-grade sarcoma ineligible for ablative metastasis therapy planned for first-line doxorubicin therapy
  • Metastatic or loco-regionally recurrent HPV-associated squamous cell carcinoma (head and neck, cervix, anus, vulva) planned for palliative first-line platinum therapy
  • Metastatic castration-resistant prostate cancer with progressive disease after recommended therapies planned for lutetium-177-PSMA therapy
Not Eligible

You will not qualify if you...

  • Contraindications to simultaneous chemotherapy or whole-body hyperthermia
  • Serious or active comorbidities that could interfere with treatment or study understanding, including:
    • Chronic inflammatory bowel disease
    • Acute infections
    • Serious cardiovascular or pulmonary conditions
    • Mental illnesses impairing study participation or understanding
    • Presence of cerebral metastases
    • Diabetes mellitus with risk of end-organ damage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Klinik für Radioonkologie und Strahlentherapie

Berlin, Germany, 13353

Actively Recruiting

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Research Team

S

Sebastian Zschaeck, MD

CONTACT

J

Julian Weingaertner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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