The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

This study is currently recruiting participants.

Verified by University Health Network, Toronto, September 2005

Sponsors and Collaborators:	University Health Network, Toronto Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188604

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 II

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Lymphedema

Drug Information available for: Selenium Sodium selenite

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase II Placebo-Controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients

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

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

Contacts

Contact: Wilfred Levin, MD

416-946-2127

wilfred.levin@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Wilfred Levin, MD 416-946-2127 wilfred.levin@rmp.uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Wilfred Levin, MD

Princess Margaret Hospital, Canada

More Information

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

Study placed in the following topic categories:

Lymphedema
Selenium
Lymphatic Diseases
Skin Diseases

Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009