Update on HOT II Trial – Last call for volunteers

Following a further extension of the accrual period for HOT II, 75% of the target sample has undergone the consent process. Treatment is delivered at participating hyperbaric medicine centres in Cardiff, Chichester, Great Yarmouth, Hull, London (Leytonstone and St John's Wood), Plymouth, Poole and Rugby. Assessments are carried out at the Royal Marsden Hospital in London, with the option of postal consent for patients unable to make more than one journey.

As there is a 3-month run-in period, accrual needs to finish at the end of March 2012 in order for all volunteers to be treated by the end of the year. Although there is a list of patients in work-up for the study, the trial is still looking for 5-10 additional volunteers who may be interested in taking part. The HOT II Trial Coordinator would therefore be grateful if you could let her know of any potentially suitable volunteers amongst your patients AS SOON AS POSSIBLE.

For further information or to refer a patient, please see below.
Thank you for your help.

Grace Sharp
HOT II Trial Coordinator

HOT II summary and contact details

HOT II is a randomised double-blind controlled phase III trial of hyperbaric oxygen in patients suffering long-term adverse effects of radiotherapy (RT) for pelvic cancer, funded by Cancer Research UK and the Department of Health (ISRCTN 86894066). It aims to test the efficacy of HBO in permanently reducing gastrointestinal symptoms caused by pelvic radiotherapy at least 12 months before and which persist despite optimal gastroenterological management.

If you have patients with chronic RT-induced symptoms in your clinic who fit the following main inclusion criteria:
- Past history of cancer of the rectum, prostate, testis, bladder, uterine cervix, uterine corpus or ovary
- Bowel symptoms due to RT: diarrhoea, faecal incontinence, bleeding etc
- Radiotherapy at least 12 months ago
please ask them to contact Grace Sharp This e-mail address is being protected from spambots. You need JavaScript enabled to view it , or forward their contact details to her. She will send them a copy of the patient information sheet and establish eligibility.

Chief & Principal Investigators:
Dr Jervoise Andreyev, Consultant Gastroenterologist in Pelvic Radiation Disease
Prof John Yarnold, Consultant Clinical Oncologist

For further information, please see Royal Marsden HOT-II or contact Grace Sharp directly at the address below:
Grace Sharp
HOT II Trial Coordinator
Professor Yarnold's Office
Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT
Tel: 0208 661 3273, Fax: 0208 661 3107, Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

The UK IBD Genetics Consortium has started recruitment for the PRED4 study, which is now open in a number of sites. The team is currently busy opening the rest of the sites in the UK (similar to the 5-ASA-induced nephrotoxicity study). These studies are investigating drug-related rare adverse events and aim to identify clinically useful genetic markers that predict serious drug side effects, in particular:
• Thiopurine-induced pancreatitis
• Thiopurine-induced leucopaenia
• Anti-TNF-induced demyelination
• PPI-induced nephritis.

Further information can be found at UK IBD Genetics Consortium and in the attached file.

• PRED 4 [ 32 kb ]

The NIHR CCRN produces a newsletter for the Specialty Groups.

• January 2012 [393 kb]
• December 2011 [500 kb]
• November 2011  [630 kb]
• October 2011  [444 kb]
• September 2011  [300 kb]
• July 2011  [200 kb]

HOT-II: Randomised double-blind controlled phase III trial of hyperbaric oxygen therapy in patients suffering long-term adverse effects of radiotherapy for pelvic cancer

We want to let you know about a randomised double-blind placebo-controlled trial of hyperbaric oxygen (HBO) therapy for men and women with radiation-induced bowel injury.

It aims to test the efficacy of HBO in permanently reducing gastrointestinal symptoms caused by pelvic radiotherapy at least 12 months before and which persist despite optimal gastroenterological management.

Clinical trial recruitment to GI and hepatology trials across the UK has shown further promising increases. There has also been a significant increase in participating centres for multi-centre studies, and continuing progress in BRAG status (see bottom of article). Nationally the target of doubling recruitment to high quality trials has already been met, 18 months ahead of schedule. The only disappointments are the slow rate of expansion of the GI portfolio, and the relative paucity of commercial studies coming through.