Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-30 @ 3:46 AM
Study NCT ID:
NCT01087268
Status:
UNKNOWN
Last Update Posted:
2011-07-15
First Post:
2010-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
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)
Status:
UNKNOWN
Status Verified Date:
2010-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Radiation therapy can cause long-term adverse effects. Hyperbaric oxygen therapy may be effective in lessening gastrointestinal symptoms caused by radiation therapy given for pelvic cancer. It is not yet known whether high-pressure oxygen is effective in treating adverse effects caused by radiation therapy.
PURPOSE: This randomized phase III trial is studying hyperbaric oxygen therapy to see how well it works in treating long-term gastrointestinal adverse effects caused by radiation therapy in patients with pelvic cancer.
PURPOSE: This randomized phase III trial is studying hyperbaric oxygen therapy to see how well it works in treating long-term gastrointestinal adverse effects caused by radiation therapy in patients with pelvic cancer.
Detailed 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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: