Effect of organic selenium on the treatment of breast cancer-related lymphedema

The effect of selenium-enriched saccharomyces cerevisiae on the improvement of clinical-stage, limb circumference, skinfold index, sense of heaviness, quality of life, and inflammatory and oxidative stress biomarkers in patients with breast cancer-related lymphedema: A triple-blind randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20131009014957N12

Enrollment

Registered

2022-04-07

Start date

2022-05-21

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer-Related Lymph edema. Postprocedural disorders of circulatory system, not elsewhere classified

Interventions

Intervention 1: Intervention group: They will take one 500 mg S.cerevisiae yeast capsule per day containing 400, 300, and 200 micrograms of organic selenium for the first, second, and third 20 days fo

Eligibility

Sex/Gender

Female

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: The first or second stage of breast cancer-related lymphedema Unilateral arm lymphedema Body mass index between 18.5 to 30

Exclusion criteria

Exclusion criteria: The presence of bilateral lymphedema The existence of known metastasis The existence of diseases leading to edema such as heart and kidney failure.

Design outcomes

Primary

Measure	Time frame
Limb circumference (arm, forearm, wrist). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Tape meter.;Skinfold thickness. Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using the specified formula.;Quality of life score. Timepoint: Baseline and 60 days after the intervention. Method of measurement: WHOQOL-BREF standard quality of life questionnaire.	—

Measure

Time frame

Limb circumference (arm, forearm, wrist). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Tape meter.;Skinfold thickness. Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using the specified formula.;Quality of life score. Timepoint: Baseline and 60 days after the intervention. Method of measurement: WHOQOL-BREF standard quality of life questionnaire.

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Secondary

Measure	Time frame
Clinical stage of lymphedema. Timepoint: Baseline and 60 days after the intervention. Method of measurement: According to the staging system of International Society of Lymphology.;Heaviness and tiredness feeling. Timepoint: Baseline and 60 days after the intervention. Method of measurement: Numerical pain rating scale (NRS).;Serum inflammatory factors (High-sensitivity C-reactive Protein, Interleukin 6). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using ELISA method and Immunoturbodimetry.;Oxidative stress biomarkers (Malondialdehyde and Glutathione peroxidase). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) method.;The frequency of probable side effects resulting from supplement use such as nausea, diarrhea, and stomach ache. Timepoint: During and after the intervention. Method of measurement: Questionnaire.;Satisfaction with medication. Timepoint: During and after the intervention. Method of measurement: Satisfaction rate questionnaire.	—

Measure

Time frame

Clinical stage of lymphedema. Timepoint: Baseline and 60 days after the intervention. Method of measurement: According to the staging system of International Society of Lymphology.;Heaviness and tiredness feeling. Timepoint: Baseline and 60 days after the intervention. Method of measurement: Numerical pain rating scale (NRS).;Serum inflammatory factors (High-sensitivity C-reactive Protein, Interleukin 6). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using ELISA method and Immunoturbodimetry.;Oxidative stress biomarkers (Malondialdehyde and Glutathione peroxidase). Timepoint: Baseline and 60 days after the intervention. Method of measurement: Using enzyme-linked immunosorbent assay (ELISA) method.;The frequency of probable side effects resulting from supplement use such as nausea, diarrhea, and stomach ache. Timepoint: During and after the intervention. Method of measurement: Questionnaire.;Satisfaction with medication. Timepoint: During and after the intervention. Method of measurement: Satisfaction rate questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzizeh Farshbaf-Khalili

Tabriz University of Medical Sciences

farshbafa@tbzmed.ac.ir+98 41 3337 1134

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026