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The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

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ClinicalTrials.gov Identifier: NCT00188604
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 13, 2010
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Lymphedema Drug: sodium selenite Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To assess the toxicity of selenium.
  2. To assess the association of selenium, quality of life and limb function.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188604


Locations
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Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
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Principal Investigator: Wilfred Levin, MD Princess Margaret Hospital, Canada
More Information
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ClinicalTrials.gov Identifier: NCT00188604     History of Changes
Other Study ID Numbers: UHN REB 03-0741-C
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 13, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Selenium
Selenious Acid
 Sodium Selenite
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances