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

Phase 3

Completed

• Conditions: Pelvic cancer; Cancer

• Registration Number: ISRCTN86894066
• Lead Sponsor: Institute of Cancer Research (UK)

Brief Summary

2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26703894 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-31
• Study Completion: 2013-12-01
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified