Safety Study of Whole Body Hyperthermia for Advanced Cancer (MATTERS)

A Mono-centric, First In-human (FIH), Safety and Preliminary Efficacy Study of (Neo)Adjuvant, Model-based, Whole-body Hyperthermia (WBHT) Treatment in Advanced Solid Cancer Patients or Stage IV (TxNxM1) Metastatic Pancreatic Adenocarcinoma Patients

Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy. It has shown effect in animal experiments and clinical practice. The sponsor has developed a novel device to use hyperthermia for advanced cancer. This study is to prove the safety in human patients of this device & therapy and get the first data on efficacy.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer; Pancreatic Cancer Metastatic
• Intervention / Treatment: Device: Whole body hyperthermia; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Patients between 18- and 75-years of age at time of signing the informed consent
2. Patients with advanced solid cancer (for cohort A1, A2 only) or metastatic pancreatic adenocarcinoma confirmed by histology (for cohort B/C/D only)
3. Patients previously treated or under treatment with standard of care treatment (cohort B/C/D only) or patients without treatment options
4. WHO performance status ≤ 1(see appendix V)
5. Maximum waist circumference ≤ 150 cm
6. Weight ≤ 100 kg
7. Height ≤ 1,90 m
8. Adequate liver structure (confirmed by CT scan) allowing the placement of the liver sensor
9. No (prostate) pathology that would interfere with the placement of the bladder catheter

10. Adequate bone marrow function defined as

    1. white blood cell count ≥ 2000/µl
    2. neutrophils ≥ 1500 cells/μL
    3. platelets ≥ 100 x 109/L
    4. hemoglobin ≥ 10 g/dl documented within 1 week prior to first treatment

11. Adequate coagulation defined as

    1. PT (%) ≥ 70%
    2. aPTT ≤ ULN
    3. Von Willebrand Factor Antigen ≥ LLN
    4. Von Willebrand Factor Activity ≥ LLN
    5. PFA COL/EPI CT ≤ 1.15 ULN
    6. PFA COL/ADP CT ≤ 1.15 ULN

12. Adequate liver function defined as

    1. Transaminases (AST, ALT) ≤ 2.5 x ULN or ≤ 5.0 in presence of liver metastasis
    2. bilirubin ≤ 2 x ULN documented

13. Adequate renal function defined as

    1. serum creatinine ≤ 1.6 mg/dL (male); ≤ 1.3 mg/dL (female);
    2. albumin ≥ 30g/L
    3. calculated eGFR ≥ 60 mL/min (CKD-EPI equation) documented within 1 week prior to randomization
14. No blood donation 3 months prior to the WBHT treatment
15. No participation in other clinical trial 4 weeks prior to the WBHT treatment
16. No biological therapy 4 weeks prior to the WBHT treatment or during WBHT treatment
17. No surgery 4 weeks prior to the WBHT treatment
18. No radiotherapy 3 weeks prior to the WBHT treatment or during WBHT treatment
19. No chemotherapy 1 week prior to the WBHT treatment (for cohort A/B/C/D) or during WBHT treatment (for Cohort A1/A2)
20. No anti-platelet aggregation medication intake from 5 days prior to the first WBHT treatment until 5 days after the last treatment
21. No anticoagulant medication intake between screening and last follow-up visit. However, if deemed necessary by the investigator, the patient may receive prophylactic Low Molecular Weight Heparin on the day prior to the first WBHT treatment until 10 days after the last WBHT treatment
22. No transdermal patches during participation in the study
23. No piercings (internally or externally)during WBHT treatment
24. Life expectancy of at least 18 weeks
25. Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
26. Written informed consent must be given according to good clinical practice and national/local regulations.

Exclusion criteria:

1. Pregnant or breastfeeding women (based on HCG levels)
2. Presence of brain metastasis (known or suspected)
3. Other malignant diseases in the medical history during the last 5 years (exceptions: carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin)
4. Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk, coronary stenting or myocardial infarction in the last year
5. Clinically significant pulmonary disease which might interfere with mechanical ventilation
6. History of autonomic dysfunction (due to the influence on skin blood flow)
7. History of malignant hyperthermia or a positive diagnostic test (Caffeine-Halothane Contracture test) in case of family history of malignant hyperthermia.
8. History of untreated endocrine pathology (e.g. diabetes type II, hyper- or hypothyroidism).
9. Primary diabetes type I (due to vascular complications)
10. Known allergies to drugs that will be used during the trial (e.g. anesthetic, analgesic, (chemotherapy used in cohort B/C/D))
11. Active infections not controlled by medication
12. Severe, non-healing wounds, ulcers or bone fractures
13. Organ allografts requiring immunosuppressive therapy
14. (History of) clinically significant (investigator decision) psychiatric disorder and/or psychosocial disorder that may interfere with adequate compliance to the protocol or signature of the informed consent
15. Other clinically significant disease which could impair the patient's ability to participate in the study according to the investigator's opinion
16. Participation in another clinical trial during this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A1; Three patients with advanced solid cancer will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15)	Device: Whole body hyperthermia; Whole body hyperthermia to treat stage IV cancer patients
Experimental: Cohort A2; One patient with advanced solid cancer will receive 3 hyperthermia treatments of 4 hours per treatment. The next patient with advanced solid cancer will receive 3 hyperthermia treatments of 6 hours per treatment.	Device: Whole body hyperthermia; Whole body hyperthermia to treat stage IV cancer patients
Experimental: Cohort B; Three pancreatic cancer patients will be subjected to three hyperthermia treatments (2 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.	Device: Whole body hyperthermia; Whole body hyperthermia to treat stage IV cancer patients; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.; Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy
Experimental: Cohort C; Three pancreatic cancer patients will be subjected to three hyperthermia treatments (4 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.	Device: Whole body hyperthermia; Whole body hyperthermia to treat stage IV cancer patients; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.; Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy
Experimental: Cohort D; Three pancreatic cancer patients will be subjected to three hyperthermia treatments (6 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.	Device: Whole body hyperthermia; Whole body hyperthermia to treat stage IV cancer patients; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines.; Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse device events (ADEs) in relation to the medical device	4 weeks after last treatment
Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters	4 weeks after last treatment
Incidence of adverse events (AEs) related to WBHT treatment alone or in combination with SOC chemotherapy according to the NCCN guidelines. nab-paclitaxel or gemcitabine alone	4 weeks after last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evolution of CA19-9 (U/ml)	The evolution of this clinically significant biological parameter will be measured compared to baseline	4 weeks after last treatment
evolution of CEA (ng/ml)	The evolution of this clinically significant biological parameter will be measured compared to baseline	4 weeks after last treatment
based on the three primary outcome measures, guidance will be drafted for phase II treatment duration in combination with chemotherapy dosing.		4 weeks after last treatment

Collaborators and Investigators

• Sponsor: ElmediX
• Investigators: Principal Investigator: Marc Peeters, MD PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): December 25, 2024
• Study Completion (Actual): December 25, 2024

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia
• Other Study ID Numbers: MATTERS 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No