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

Institute of Cancer Research (UK)0 个研究点目标入组 84 人开始时间: 2008年3月31日最近更新: 2022年11月7日

适应症

试验速览

•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

•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

发起方

Institute of Cancer Research (UK)