HOT II clinical trial
ISRCTN 86894066
HOT II is a randomised double-blind controlled Phase III trial of hyperbaric oxygen therapy in patients suffering long-term adverse effects of radiotherapy for pelvic cancer. It is currently recruiting.
Aim of the trial
The HOT II trial aims to test the clinical benefits of hyperbaric oxygen therapy in reducing dysfunction in patients developing iatrogenic gastrointestinal symptoms as a result of previous radical pelvic radiotherapy for cancer, which was completed at least one year previously.
75 patients eligible for the study will be randomised by a hyperbaric technician using a 2:1 ratio of treatment:control.
The trial is funded by Cancer Research UK and the Department of Health, and sponsored by The Institute of Cancer Research and The Royal Marsden. It is being led by Dr Jervoise Andreyev, Consultant Gastroenterologist in Pelvic Radiation Disease, and Professor John Yarnold, Consultant Clinical Oncologist.
Eligibility criteria
Inclusion criteria
- Age over 18 years.
- Past history of a malignant pelvic neoplasm (T1-3 N0-1 M0), including carcinoma of the rectum, prostate, testis, bladder, uterine cervix, uterine corpus and ovary.
- A minimum 12 months follow-up post-radiotherapy.
- No evidence of cancer recurrence.
- Gastrointestinal symptoms attributable to prior radiotherapy: grade 2 or higher in any LENT SOMA category, or grade 1 with difficult intermittent symptoms.
- Symptoms are not relieved by appropriate lifestyle advice and medication over a three-month period.
- Physical and psychological fitness for hyperbaric oxygen therapy.
- Written informed consent and availability for follow-up.
Exclusion criteria
- Surgery for rectal cancer.
- Prior hyperbaric oxygen therapy (excluding treatment for decompression illness).
- Prior treatment with even a single dose of bleomycin.
- Claustrophobia.
- Epilepsy.
- Chronic obstructive airways disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax.
- Previous middle or inner ear operations (except grommets and similar procedures) and/or irremediable inability to equalise middle ear pressure.
- Contra-indication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy.
Hyperbaric treatment centres
- Diving Diseases Research Centre, The Hyperbaric Medical Centre, Tamar Science Park, Research Way, Plymouth, Devon PL6 8BU
- East of England Hyperbaric Unit, James Paget University Hospitals NHS Foundation Trust, Lowestoft Road, Gorleston, Great Yarmouth NR31 6LA
- Hyperbaric Medicine Unit, St Richard’s Hospital, Spitalfield Lane, Chichester, West Sussex PO19 6SE
- Hyperbaric Unit, BUPA Hospital Hull & East Riding, Lowfield Road, Anlaby, Kingston-upon-Hull HU10 7AZ
- London Diving Chamber, Hospital of St John and St Elizabeth, 60 Grove Road, St John's Wood, London NW8 9NH
- London Hyperbaric and Wound Healing Centre, Whipps Cross University Hospital, Leytonstone, London E11 1NR
- Midlands Diving Chamber Ltd, Hospital of St Cross, Barby Road, Rugby, Warwickshire CV22 5PX
- The Diver Clinic (Atlantic Enterprise UK Ltd), 7 Parkstone Road, Poole, Dorset BH15 2NN
- South Wales Hyperbaric Medical Centre, Spire Cardiff Hospital, Croescadarn Road, Pentwyn, Cardiff, Wales CF23 8XL
Find out more
Please contact Grace Sharp, Trial Coordinator, on 020 8661 3273 or grace.sharp@icr.ac.uk.