NCT00188604

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 13, 2010

Status Verified

August 1, 2010

Enrollment Period

5 years

First QC Date

September 12, 2005

Last Update Submit

August 12, 2010

Conditions

Breast NeoplasmsLymphedema

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • To assess the toxicity of selenium.

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

Interventions

sodium seleniteDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Interventions

Sodium Selenite

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Selenious AcidSelenium CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Wilfred Levin, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 13, 2010

Record last verified: 2010-08

Locations

CA(1)