High-Pressure oxygen therapy for long-term adverse effects of radiotherapy for pelvic cancer

Phase 1

Active, not recruiting

• Conditions: Chronic radiation-induced gastrointestinal symptoms; MedDRA version: 14.1 Level: PT Classification code 10057480 Term: Hyperbaric oxygen therapy System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-002152-26-GB
• Lead Sponsor: The Royal Marsden Foundation Trust and The Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-18
• Study Completion: 2013-11-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

i)Age over 18 years.
ii)Past history of a malignant pelvic neoplasm (T1-4 N0-2 M0), including carcinoma of the rectum, prostate, testis, bladder, uterine cervix, uterine corpus, vagina, vulva and ovary.
iii)A minimum 12 months follow-up post-radiotherapy (36 months for patients with past history of stage T4 and/or N2 disease).
iv)No evidence of cancer recurrence.
v)Gastrointestinal symptoms attributable to prior radiotherapy: grade 2 or higher in any LENT SOMA category, or grade 1 with difficult intermittent symptoms.
vi)Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period.
vii)Physical and psychological fitness for HBO therapy.
viii)Written informed consent and availability for follow up.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

i)Surgery for rectal cancer.
ii)Prior hyperbaric oxygen therapy (excluding treatment for decompression illness).
iii)Prior treatment with even a single dose of bleomycin.
iv)Claustrophobia.
v)Epilepsy.
vi)Chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax.
vii)Previous middle/inner ear operations (except grommets and similar procedures) &/or irremediable inability to equalise middle ear pressure.
viii)Contra-indication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified