Potential of Moderate Whole Body Hyperthermia to Enhance Response

NCT05821166 | Recruiting Phase 2 DMC

• 1 other identifier: POWER
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

• change in the number of circulating tumor cells before therapy vs after therapy

  ANCOVA is used as the statistical methodology. The change in the number of circulating tumor cells three months after the start of therapy is the dependent variable, the group (intervention or control) and the number of circulating tumor cells as well as the tumor entity (6 groups) are independent variables. Case number estimation: So far there are no studies that have examined this outcome. We assume that the intervention effect is moderate and that an effect size of 0.6 to 0.7 can be achieved. If 36 patients per arm are included in the study, an effect size (Cohen's d) of 0.67 or greater at a two-sided significance level of α=0.05 with a power of 80% can be demonstrated using the t-test for independent samples.

  Test therapy naive versus three months after the start of therapy

Secondary Outcomes (10)

• Response of the tumors

  three months after the start of therapy

• Quality of life of the patients

  measured before and 2 weeks after the end of therapy (end of therapy is determined as the last planned mWBH session) or at a comparable time in the control group

• influence of mWBH on depressive/dysthymic moods/episodes as well as on fatigue symptoms

  Follow-up visits, in total 2 years follow up time

• impact of patient-reported organ-specific functional impairment

  Follow-up visits, in total 2 years follow up time

• influence of mWBH on different leukocyte sub-populations and the plasma concentration of cytokines/proteins, which indicate a suspected predictive effect on the response to immunotherapy.

  measurement before treatment compared with the one after treatment

Study Arms (2)

mWBH

EXPERIMENTAL

patients receiving moderate Whole Body Hyperthermia

Device: moderate Whole Body Hyperthermia (mWBH)

Control group

NO INTERVENTION

Patients do not receive moderate Whole Body Hyperthermia

Interventions

moderate Whole Body Hyperthermia (mWBH) DEVICE

Patients receiving 3-4 times mWBH

mWBH

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Klinik für Radioonkologie und Strahlentherapie

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Sebastian Zschaeck, MD

CONTACT

030450650764; sebastian.zschaeck@charite.de

Julian Weingaertner, MD

CONTACT

030450657057; julian.weingaertner@charite.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Sebastian Zschaeck

Model Details: Randomization into intervention group (additional MWB-HT) and standard care (chemotherapy / immunotherapy) and control group (no MWB-HT), only standard care

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: April 20, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)