Condition category
Cancer
Date applied
05/03/2008
Date assigned
31/03/2008
Last edited
21/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof John Yarnold

ORCID ID

Contact details

The Royal Marsden Hospital
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 (0)20 8661 3891/3388
John.Yarnold@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01087268

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

HOT II

Study hypothesis

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

Central Office for Research Ethics Committees (COREC), 23/09/2008

Study design

Multicentre double-blind randomised controlled phase III trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.royalmarsden.nhs.uk/research/clinical-trials/Documents/hot-ii-patient-information-sheet.pdf

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/11/2008

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant 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

Recruitment start date

27/06/2011

Recruitment end date

15/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal Marsden Hospital
London
SW3 6JJ
United Kingdom

Trial participating centre

Hyperbaric Medicine Unit
St Richards Hospital
Chichester
PO19 6SE
United Kingdom

Trial participating centre

London Hyperbaric
Whipps Cross University Hospital
London
E11 1NR
United Kingdom

Trial participating centre

DDRC Healthcare
Plymouth
PL6 8BU
United Kingdom

Trial participating centre

North of England Hyperbaric Services, Spire
East Riding Hospital
Kingston-upon-Hull
HU10 7AZ
United Kingdom

Trial participating centre

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

Trial participating centre

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

Trial participating centre

The Diver Clinic
Poole
BH15 2NN
United Kingdom

Trial participating centre

East of England Hyperbaric Unit
James Paget University Hospitals NHS Found Trust
Great Yarmouth
NR31 6LA
United Kingdom

Trial participating centre

North West Emergency Recompression Unit
Murrayfield Hospital
Wirral
CH61 1AU
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C181/A9694)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes