Trial Information
A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Wilfred Levin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 03-0741-C
NCT ID:
NCT00188604
Start Date:
January 2004
Completion Date:
January 2009
Related Keywords:
- Breast Neoplasms
- Lymphedema
- Breast Neoplasms
- Neoplasms
- Lymphedema