Pelvic cancer Cancer Pelvic cancer
Conditions
Interventions
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
Sponsors
Institute of Cancer Research (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed