A trial looking at Hyperbaric Oxygen (HBO) Treatment for people who have long-term side effects following radiotherapy for pelvic cancer

ISRCTN	ISRCTN86894066
DOI	https://doi.org/10.1186/ISRCTN86894066
ClinicalTrials.gov (NCT)	NCT01087268
Protocol serial number	N/A
Sponsor	Institute of Cancer Research (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C181/A9694)

Submission date: 05/03/2008
Registration date: 31/03/2008
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-high-pressure-oxygen-for-radiotherapy-side-effects

Contact information

Prof John Yarnold
Scientific

The Royal Marsden Hospital
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom

Phone	+44 (0)20 8661 3891/3388
Email	John.Yarnold@icr.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre double-blind randomised controlled phase III trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised double-blind phase III trial of hyperbaric oxygen therapy in patients suffering long-term adverse effects of radiotherapy for pelvic cancer
Study acronym	HOT II
Study objectives	Curative radiotherapy is prescribed to an increasing number (12,000 per year) of UK patients with pelvic malignancies, and more individuals are living with a significant legacy of treatment related morbidity. The UK prevalence of radiation-induced bowel morbidity causing significant impairment of physical functioning is unknown, but the US estimate is one million individuals. The primary goal of this trial is to test the clinical benefits of high pressure oxygen therapy in restoring normal bowel function to patients suffering chronic radiation-induced gastrointestinal complications following curative radiotherapy for pelvic cancers. On 09/10/2008 the overall trial start date was changed from 01/08/2008 to 01/11/2008. On 21/04/2015 the overall trial end date was changed from 01/08/2011 to 01/12/2013.
Ethics approval(s)	Central Office for Research Ethics Committees (COREC), 23/09/2008
Health condition(s) or problem(s) studied	Pelvic cancer
Intervention	Treatment group: Patients are compressed to 2.4 atmospheres (ATA) in a hyperbaric chamber and breathe 100% oxygen at pressure following a RN66 (Royal Navy) protocol. The total time at 2.4 ATA is 90 minutes. Each participant receives 40 pressure exposures (five days per week for eight weeks). Control group: Patients are compressed to 1.3 ATA in a hyperbaric chamber and breathe 21% oxygen (air). The total time at 1.3 ATA is 90 minutes. Each participant receives 40 pressure exposures (five days per week for eight weeks). Total follow up for both treatment arms is 12 months.
Intervention type	Other
Primary outcome measure(s)	Patient self assessment using the modified inflammatory bowel disease questionnaire (IBDQ), completed by the patient before treatment, 3, 6, 9 and 12 months post-treatment.
Key secondary outcome measure(s)	1. Physician assessment of bowel dysfunction using LENT SOMA scales of radiation injury, carried out before treatment, within two weeks of treatment finishing and at 12 months post-treatment 2. Patient self-assessments using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) and defaecation problem subscale of the colorectal cancer-specific quality of life questionnaire module (QLQ-CR38), carried out before treatment, 3, 6, 9 and 12 months post-treatment 3. Photographic images of rectal mucosa taken via flexible sigmoidoscopy, taken before treatment, within 2 weeks of treatment finishing and at 12 months post-treatment
Completion date	01/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	75
Total final enrolment	84
Key inclusion criteria	As of 09/10/2008, point five of the below inclusion criteria has been amended to: 5. Gastrointestinal symptoms attributable to prior radiotherapy (late effects in normal tissues subjective, objective, management and analytic scales [LENT SOMA] grade 1 with difficult intermittent symptoms, grades 2 - 3, plus patients with grade 4 rectal bleeding At this time, the following criteria was also added: 8. Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period Initial information at time of registration: 1. Age over 18 years, either sex 2. Past history of a malignant pelvic neoplasm (T1-3 N0-1 M0) 3. Minimum 12 months follow-up post-radiotherapy 4. No evidence of cancer recurrence 5. Grade 1 - 3 gastrointestinal morbidity (late effects in normal tissues subjective, objective, management and analytic scales [LENT SOMA]) not present before radiotherapy 6. Physical and psychological fitness for hyperbaric therapy 7. Written informed consent and available for follow-up
Key exclusion criteria	As of 09/10/2008, the following points were added to the exclusion criteria: 11. Surgery for rectal cancer 12. Prior treatment with even a single dose of bleomycin Initial information at time of registration: 1. Prior hyperbaric oxygen therapy 2. Claustrophobia 3. Epilepsy 4. Chronic obstructive airways disease 5. Bullous lung disease 6. Acute or chronic pulmonary infection 7. Uncontrolled asthma 8. Untreated pneumothorax 9. Previous middle/inner ear operations (except grommets and similar procedures) and/or irremediable inability to equalise middle ear pressure 10. Contra-indication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy
Date of first enrolment	27/06/2011
Date of final enrolment	15/10/2012

Locations

Countries of recruitment

United Kingdom
England
Wales

Study participating centres

The Royal Marsden Hospital

London
SW3 6JJ
United Kingdom

Hyperbaric Medicine Unit

St Richards Hospital
Chichester
PO19 6SE
United Kingdom

London Hyperbaric

Whipps Cross University Hospital
London
E11 1NR
United Kingdom

DDRC Healthcare

Plymouth
PL6 8BU
United Kingdom

North of England Hyperbaric Services, Spire

East Riding Hospital
Kingston-upon-Hull
HU10 7AZ
United Kingdom

DDRC Healthcare

South Wales Hyperbaric Medical Centre
Spire Cardiff Hospital
Cardiff
CF23 8XL
United Kingdom

London Diving Chamber

Hospital of St John and St Elizabeth
London
NW9 9NH
United Kingdom

The Diver Clinic

Poole
BH15 2NN
United Kingdom

East of England Hyperbaric Unit

James Paget University Hospitals NHS Found Trust
Great Yarmouth
NR31 6LA
United Kingdom

North West Emergency Recompression Unit

Murrayfield Hospital
Wirral
CH61 1AU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
22/09/2017: Internal review.
07/07/2017: Publication reference added.