Back to resultsThe Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
Primary Purpose
Breast Neoplasms, Lymphedema
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
sodium selenite
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
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
Sites / Locations
- Princess Margaret Hospital
Outcomes
Primary Outcome Measures
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
To assess the toxicity of selenium.
To assess the association of selenium, quality of life and limb function.
Full Information
NCT ID
NCT00188604
First Posted
September 12, 2005
Last Updated
August 12, 2010
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00188604
Brief Title
The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
Official Title
A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sodium selenite
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess the toxicity of selenium.
Title
To assess the association of selenium, quality of life and limb function.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfred Levin, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
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The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
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