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 study involves delivering heat treatment (thermotherapy or hyperthermia) in combination with radiotherapy (RT). Heat therapy (HT) is defined as an elevation of tissue or body temperature, and it can be used as a cancer treatment method due to the profound effect that heat has on cells. In this study, HT will be used alongside RT to enhance the effect of RT. Treatment will involve heating the tumour and the surrounding area using a specialised machine, a water-filtered infra-red-A (wIRA) superficial HT machine. HT has been shown to make cancer cells more sensitive to other cancer treatments such as RT, chemotherapy and immunotherapy and is currently in use in multiple cancer centres across Europe and Switzerland but not in the UK.

Guy's Cancer centre is the first in the UK to acquire this CE marked superficial wIRA hyperthermia machine. Our aim is to assess the real-world implementation of HT using wIRA in combination with RT in patients with cancers that are suitable for superficial hyperthermia treatment.

This is a prospective study to assess the real-world implementation of superficial hyperthermia (wIRA) in combination with SOC palliative radiotherapy in cancer patients not suitable for radical treatment and have superficial lesion(s) suitable for wIRA treatment. Three cohorts of patients will be invited:

1. HNSCC (Head and neck squamous cell carcinoma) i) Inoperable/incurable locally advanced or recurrent/metastatic HNSCC with no previous radiotherapy treatment ii) Inoperable/incurable locally advanced or recurrent/metastatic HNSCC with previous radiotherapy treatment (re-irradiation)
2. cSCC (Cutaneous squamous cell carcinoma) in the head and neck region i) Inoperable/incurable locally advanced or recurrent/metastatic cSCC with no previous radiotherapy treatment ii) Inoperable/incurable locally advanced or recurrent/metastatic cSCC with previous radiotherapy treatment (re-irradiation) LRBC
3. LRBC (locally recurrent breast cancer) with previous radiotherapy treatment (re-irradiation)

All patients consenting to the study will be treated with HT. The patients will receive hyperthermia either once a week or twice a week using hydrosun® TWH1500 with palliative radiotherapy. The patients will receive hyperthermia treatment for 1 hour before going for palliative radiotherapy as per standard of care. For patients who will undergo 20Gy/5# over one week, they will receive hyperthermia two times per week during their treatment. For patients undergoing 27Gy/6#, they will receive hyperthermia once a week for three weeks during the course of palliative radiotherapy.