Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00077090|
Recruitment Status : Unknown
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 11, 2004
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Lymphedema Perioperative/Postoperative Complications Radiation Fibrosis||Drug: hyperbaric oxygen||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer|
|Study Start Date :||April 2004|
- Volume of the affected limb, expressed as a percentage of the contralateral limb Volume on the day of measurement, as measured by perometer 12 months after baseline assessment
- Patient self-assessments, using specific quality of life scale in upper limb lymphoedema and the UK SF-36 Health Survey Questionnaire, at 3, 6, 9 and 12 months after baseline assessment
- 99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
- Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077090
|Royal Hospital Haslar|
|Gosport, England, United Kingdom, PO12 2AA|
|Hull Royal Infirmary|
|Hull, England, United Kingdom, HU3 2KZ|
|London Hyperbaric Medicine Limited at Whipps Cross Hospital|
|London, England, United Kingdom, E11 1NR|
|Diving Diseases Research Centre|
|Plymouth, England, United Kingdom, PL6 8BU|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||John R. Yarnold, MD, FRCR||Royal Marsden NHS Foundation Trust|