Breast Neoplasms, Lymphedema
Conditions
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.
Interventions
DRUGsodium selenite
Sponsors
Princess Margaret Hospital, Canada
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess the toxicity of selenium. | — |
| To assess the association of selenium, quality of life and limb function. | — |
Countries
Canada
Outcome results
None listed