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The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Completed
Phase 2

Conditions

Lymphedema
Breast Neoplasms

Treatments

Drug: sodium selenite

Study type

Interventional

Funder types

Other

Identifiers

NCT00188604
UHN REB 03-0741-C

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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