Adding superficial heat therapy (wIRA) to standard palliative radiotherapy
Prospective Study to Assess the Real-world Implementation of Thermotherapy Using wIRA (Water-filtered Infrared A Superficial Hyperthermia) in Addition to Standard of Care (SOC) Palliative Radiotherapy (RT)
This project will test whether adding superficial hyperthermia (wIRA) to standard palliative radiotherapy helps control superficial tumours in adults with inoperable or recurrent head and neck, cutaneous, or recurrent breast cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT06659146 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center implementation of water-filtered infra-red-A (wIRA) superficial hyperthermia given alongside standard palliative radiotherapy for patients with superficial lesions from head and neck, cutaneous, or recurrent breast cancers. Patients who meet inclusion criteria will receive the specified palliative radiotherapy regimen with scheduled wIRA sessions targeting the tumour and surrounding area to increase local temperature. The primary outcome is the best objective response rate (ORR) of the treated superficial lesions, with safety and real-world feasibility also recorded. The protocol focuses on patients unsuitable for radical treatment and captures practical delivery data for wider adoption in the UK.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed inoperable/incurable or recurrent/metastatic head and neck squamous cell carcinoma, cutaneous squamous cell carcinoma, or recurrent breast cancer who have at least one superficial lesion suitable for wIRA, are planned for the protocol palliative radiotherapy regimens, have ECOG 0–1, and can consent.
Not a fit: Patients without a superficial lesion suitable for the wIRA device, those not eligible for the pre-specified palliative radiotherapy dose/fractionation, or those unable to cooperate (including poor performance status or significant psychiatric/substance issues) are unlikely to benefit.
Why it matters
Potential benefit: If successful, adding superficial hyperthermia could improve local tumour control and symptom relief for patients receiving palliative radiotherapy to superficial lesions.
How similar studies have performed: Hyperthermia combined with radiotherapy has shown encouraging local control and sensitizing effects in prior European reports and is used at several continental centres, but UK experience and definitive randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient with histologically confirmed incurable or inoperable cancers with disease \[at least one superficial lesion(s) or lymph node(s)\] suitable for hydrosun® TWH1500 treatment 2. Patient undergoing standard of care palliative radiotherapy (suitable with the pre-specified dose and fractionation in the protocol 3. Aged ≥18 years old 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 5. Patient with capacity to consent Exclusion Criteria: 1. No superficial tumour lesion or lymph node that is suitable for hydrosun® TWH1500 treatment. 2. Patients are not suitable for one of the pre-specified palliative radiotherapy dose and fractionation 3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Where this trial is running
London and 1 other locations
- Guy's and St. Thomas NHS Foundation Trust — London, United Kingdom (Recruiting)
- Guy's Cancer Centre — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Anthony Kong — Clinical reader and honorary NHS consultant in clinical oncology
- Study coordinator: Anthony Kong
- Email: Anthony.Kong@kcl.ac.uk
- Phone: 44+2078486004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.