- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00188604
The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
August 12, 2010 updated by: University Health Network, Toronto
A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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To assess the toxicity of selenium.
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To assess the association of selenium, quality of life and limb function.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wilfred Levin, MD, Princess Margaret Hospital, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
August 13, 2010
Last Update Submitted That Met QC Criteria
August 12, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 03-0741-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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