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ISRCTN
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ISRCTN86894066
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ClinicalTrials.gov identifier
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Public title
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A trial looking at Hyperbaric Oxygen (HBO) Treatment for people who have long term side effects following radiotherapy for pelvic cancer
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Scientific title
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Randomised double-blind phase III trial of hyperbaric oxygen therapy in patients suffering long-term adverse effects of radiotherapy for pelvic cancer
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Acronym
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HOT II
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Ethics approval to be obtained from the Central Office for Research Ethics Committees (COREC) in May 2008.
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Study design
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Multicentre, double-blind randomised controlled phase III trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pelvic cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2008
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Anticipated end date
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01/08/2011
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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75
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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Cancer Research UK (CRUK) (UK) (ref: C181/A9694)
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Trial website
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Publications
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Contact name
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Prof
John
Yarnold
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Address
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The Royal Marsden Hospital
Downs Road
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City/town
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Sutton, Surrey
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Email
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John.Yarnold@icr.ac.uk
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Sponsor
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Institute of Cancer Research (UK)
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Address
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Downs Road
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City/town
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Sutton, Surrey
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Sponsor website:
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http://www.icr.ac.uk/
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Date applied
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05/03/2008
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Last edited
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31/03/2008
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Date ISRCTN assigned
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31/03/2008
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