Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077090
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2004-02-10
Brief Title:
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
ACTIVE_NOT_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 Hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for cancer
PURPOSE This randomized phase II trial is studying hyperbaric oxygen to see how well it works compared to standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer
PURPOSE This randomized phase II trial is studying hyperbaric oxygen to see how well it works compared to standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of hyperbaric oxygen HBO therapy vs standard management in terms of reduction of lymphedema in patients with chronic arm lymphedema after radiotherapy for cancer
Secondary
Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO therapy
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo hyperbaric oxygen therapy over 90 minutes 5 days a week for 6 weeks
Arm II Patients receive standard management Patients are followed at 3 6 9 12 and 15 months
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 63 patients 42 for arm I and 21 for arm II will be accrued for this study
Primary
Compare the efficacy of hyperbaric oxygen HBO therapy vs standard management in terms of reduction of lymphedema in patients with chronic arm lymphedema after radiotherapy for cancer
Secondary
Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO therapy
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo hyperbaric oxygen therapy over 90 minutes 5 days a week for 6 weeks
Arm II Patients receive standard management Patients are followed at 3 6 9 12 and 15 months
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 63 patients 42 for arm I and 21 for arm II will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20337 | None | None | None |
| RMNHS-HOT | None | None | None |