The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188604
• Other study ID #: UHN REB 03-0741-C
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: August 12, 2010
• Start date: January 2004
• Est. completion date: January 2009

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema

Intervention

Drug:
• sodium selenite

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the toxicity of selenium.
Secondary	To assess the association of selenium, quality of life and limb function.