A Phase 2 interventional study of hyperbaric oxygen in Breast Cancer, Lymphedema and Perioperative/Postoperative Complications, sponsored by Institute of Cancer Research, United Kingdom. Status unknown at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by Institute of Cancer Research, United Kingdom · Phase 2, Interventional, and Supportive care
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 63 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institute of Cancer Research, United Kingdom is the lead sponsor of 111 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
This study is status unknown, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.
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Institute of Cancer Research, United Kingdom