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Sponsored by: |
Institute of Cancer Research, United Kingdom |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077090 |
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 | Intervention | Phase |
---|---|---|
Breast Cancer Cancer-Related Problem/Condition |
Drug: hyperbaric oxygen |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
Official Title: | Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer |
Estimated Enrollment: | 63 |
Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Arm lymphedema
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United Kingdom, England | |
Diving Diseases Research Centre | |
Plymouth, England, United Kingdom, PL6 8BU | |
Hull Royal Infirmary | |
Hull, England, United Kingdom, HU3 2KZ | |
London Hyperbaric Medicine Limited at Whipps Cross Hospital | |
London, England, United Kingdom, E11 1NR | |
Royal Hospital Haslar | |
Gosport, England, United Kingdom, PO12 2AA | |
Royal Marsden NHS Foundation Trust - Surrey | |
Sutton, England, United Kingdom, SM2 5PT |
Study Chair: | John R. Yarnold, MD, FRCR | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000349496, RMNHS-HOT, EU-20337 |
Study First Received: | February 10, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00077090 History of Changes |
Health Authority: | United States: Federal Government |
lymphedema radiation fibrosis perioperative/postoperative complications |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Lymphedema Lymphatic Diseases Skin Diseases Postoperative Complications |
Fibrosis Breast Neoplasms Breast Diseases |
Lymphedema Lymphatic Diseases Neoplasms Neoplasms by Site |
Skin Diseases Breast Neoplasms Breast Diseases |