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The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188604
First received: September 12, 2005
Last updated: August 12, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Breast Neoplasms
Lymphedema
 Drug: sodium selenite
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

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.

Estimated Enrollment: 34
Study Start Date: January 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188604

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Wilfred Levin, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188604     History of Changes
Other Study ID Numbers: UHN REB 03-0741-C
Study First Received: September 12, 2005
Last Updated: August 12, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Lymphedema
Neoplasms by Site
 Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013