Adding superficial heat therapy (wIRA) to standard palliative radiotherapy

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.