A Phase 2 trial of Oral Sodium Selenite supplements in BCRL and SHNL

A Phase II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Oral Sodium Selenite in Patients with Cancer-Related Lymphedema (Breast and Head & Neck Cancers).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110152

Enrollment

Registered

2026-05-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: C501- Malignant neoplasm of central portion of breast Health Condition 2: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth

Interventions

Intervention1: sodium selenite: Oral sodium selenite 200 g tablets with Standard lymphedema care (compression, physiotherapy). 3. Dose regimen: Loading phase: 600 g/day (3 tablets) 7 days. Maint

Eligibility

Inclusion criteria

Inclusion criteria: 2.Histologically confirmed head and neck cancer (squamous cell carcinoma or other) and breast cancer patients treated with surgery, radiotherapy, and or chemoradiation. 3.Clinically or radiologically confirmed secondary lymphedema post radiation therapy, Grade 1 and 2 lymphedema BCRL and SHNL. 4.Ability to swallow oral medication. 5.ECOG 0 2. 6.Those who are willing to provide informed consent

Exclusion criteria

Exclusion criteria: 1.Primary (congenital or hereditary) lymphedema 2.Active infection or cellulitis within 4 weeks. 3.Patients already receiving selenium supplementation above recommended dietary allowance within 4 weeks of enrolment. 4.Patients with severe renal or hepatic impairment. 5.Head and neck cancer patients with local, regional or distant metastasis 6.Concurrent enrolment in another interventional clinical trial.

Design outcomes

Primary

Measure	Time frame
1. BCRL/ SHNL - Improvement in lymphedema grade by at least one grade 2.Incidence of all grades hematological and nonhematological adverse reactions. 3.Change in Quality of life. 4.Lymphedema recurrence rates 5. Time required for resolution of lymphedema volumeTimepoint: 1. (e.g., Grade 2 to Grade 1, or Grade 1 to Grade 0) at Week 12 2.evaluated as per CTCAE v5.0 3.(LYMQOL/EORTC QOL C30 questionnaire) from baseline to post treatment at 12 1 week. 4. 36 weeks 2 weeks of start of sodium selenite initiation 5.decrease in volume by 10% from baseline in BCRL and 2% improvement in face and neck circumference in SHNL from baseline.	—

Measure

Time frame

1. BCRL/ SHNL - Improvement in lymphedema grade by at least one grade 2.Incidence of all grades hematological and nonhematological adverse reactions. 3.Change in Quality of life. 4.Lymphedema recurrence rates 5. Time required for resolution of lymphedema volumeTimepoint: 1. (e.g., Grade 2 to Grade 1, or Grade 1 to Grade 0) at Week 12 2.evaluated as per CTCAE v5.0 3.(LYMQOL/EORTC QOL C30 questionnaire) from baseline to post treatment at 12 1 week. 4. 36 weeks 2 weeks of start of sodium selenite initiation 5.decrease in volume by 10% from baseline in BCRL and 2% improvement in face and neck circumference in SHNL from baseline.

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Secondary

Measure	Time frame
2.Incidence of all grades hematological and nonhematological adverse reactions. 3.Change in Quality of life. 4.Lymphedema recurrence rates 5. Time required for resolution of lymphedema volumeTimepoint: 2.evaluated as per CTCAE v5.0 3.(LYMQOL/EORTC QOL C30 questionnaire) from baseline to post treatment at 12 1 week. 4. 36 weeks 2 weeks of start of sodium selenite initiation 5.decrease in volume by 10% from baseline in BCRL and 2% improvement in face and neck circumference in SHNL from baseline.	—

Measure

Time frame

2.Incidence of all grades hematological and nonhematological adverse reactions. 3.Change in Quality of life. 4.Lymphedema recurrence rates 5. Time required for resolution of lymphedema volumeTimepoint: 2.evaluated as per CTCAE v5.0 3.(LYMQOL/EORTC QOL C30 questionnaire) from baseline to post treatment at 12 1 week. 4. 36 weeks 2 weeks of start of sodium selenite initiation 5.decrease in volume by 10% from baseline in BCRL and 2% improvement in face and neck circumference in SHNL from baseline.

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Countries

India

Contacts

Public ContactDr Manjunath Nookala

Homibhabha National Institute, Anushaktinagar, Mumbai, Maharashtra, India

nk.manjunath@gmail.com9920703438

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026