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 number NCT01087268
Secondary identifying numbers N/A
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

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

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

Study information

Study designMulticentre double-blind randomised controlled phase III trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet http://www.royalmarsden.nhs.uk/research/clinical-trials/Documents/hot-ii-patient-information-sheet.pdf
Scientific titleRandomised double-blind phase III trial of hyperbaric oxygen therapy in patients suffering long-term adverse effects of radiotherapy for pelvic cancer
Study acronymHOT II
Study hypothesisCurative 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
ConditionPelvic cancer
InterventionTreatment 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 typeOther
Primary outcome measurePatient self assessment using the modified inflammatory bowel disease questionnaire (IBDQ), completed by the patient before treatment, 3, 6, 9 and 12 months post-treatment.
Secondary outcome measures1. 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
Overall study start date01/11/2008
Overall study end date01/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants75
Total final enrolment84
Participant inclusion criteriaAs 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
Participant exclusion criteriaAs 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
Recruitment start date27/06/2011
Recruitment end date15/10/2012

Locations

Countries of recruitment

  • England
  • United Kingdom
  • 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

Sponsor information

Institute of Cancer Research (UK)
Research organisation

Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom

http://www.icr.ac.uk/
ROR logo https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C181/A9694)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planTo be confirmed at a later date
IPD sharing planNot 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
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.

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