Randomized Double-Blind Controlled Phase III Trial of Hyperbaric Oxygen Therapy in Patients Suffering Long-Term Adverse Effects of Radiotherapy for Pelvic Cancer (HOT II)
Description:
OBJECTIVES:
– To determine the clinical benefits of hyperbaric oxygen therapy in reducing dysfunction
in patients with pelvic cancer developing iatrogenic gastrointestinal symptoms as a
result of previous radical pelvic radiotherapy completed at least one year ago.
OUTLINE: This is a multicenter study. Patients are stratified according to center and
severity of symptoms (low vs high). Patients are randomized to 1 of 2 treatment arms.
– Arm I (treatment group): Patients undergo hyperbaric oxygen therapy over 90 minutes, 5
days a week, for 8 weeks for a total of 40 treatments. Oxygen at 100% is breathed for 30
minutes, followed by a 5-minute "air break" and a further 30 minutes of breathing
oxygen. A further 5-minute "air break" is followed by a further 30 minutes of breathing
oxygen. During the final 10 minutes of oxygen breathing, the chamber is depressurized to
ambient atmospheric pressure at a linear rate (14.2 kPa/min).
– Arm II (control group): Patients undergo hyperbaric oxygen therapy over 90 minutes, 5
days a week, for 8 weeks for a total of 40 treatments. Oxygen at 21% is breathed for 30
minutes, followed by a 5-minute "air break" and a further 30 minutes of breathing
oxygen. A further 5-minute "air break" is followed by a further 30 minutes of breathing
oxygen. During the final 10 minutes of oxygen breathing, the chamber is depressurized to
ambient atmospheric pressure at a linear rate (3 kPa/min).
Tissue samples from rectal biopsies may be collected and analyzed.
Patients complete questionnaires (Health Economics, Inflammatory Bowel Disease Questionnaire
[IBDQ], EORTC Quality of Life [QLQ]-C30, and QLQ-CR38) at baseline and then at 3, 6, 9, and
12 months after the start of treatment.
After completion of study treatment, patients are followed within 14 days and at 10 months.
Condition:
Bladder Cancer
Treatment:
questionnaire administration
Start Date:
January 2009
Sponsor:
Royal Marsden NHS Foundation Trust
For More Information:
https://clinicaltrials.gov/show/NCT01087268