The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
Phase 2
Completed
- Conditions
- Breast NeoplasmsLymphedema
- Registration Number
- NCT00188604
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
Inclusion Criteria
- patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy)
- patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy
- ECOG performance 0-2
- informed consent
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Exclusion Criteria
- active cellulitis/skin infection of the limb
- venous thrombosis of the upper limbs
- active malignancy
- any other medical condition or congenital or traumatic injury involving either limb
- patients already on selenium medication
- patients participating in another clinical study related to lymphedema
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer.
- Secondary Outcome Measures
Name Time Method To assess the toxicity of selenium. To assess the association of selenium, quality of life and limb function.
Trial Locations
- Locations (1)
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada