The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

University Health Network, Toronto34 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breast Neoplasms Lymphedema

Interventions

sodium seleniteDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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 Outcomes

To assess the toxicity of selenium.

To assess the association of selenium, quality of life and limb function.

Data from ClinicalTrials.gov

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