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A study to assess thyroid function in Breast Cancer patients receiving Supraclavicular Radiation Therapy

Prospective Study on Assessment of Thyroid Function in Breast Cancer patients receiving supraclavicular radiation therapy as a part of adjuvant therapy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099858
Enrollment
100
Registered
2025-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Radiation Therapy to Breast and its regional and Supraclavicular nodes: any of the following dose fractionation schedule to be followed: 1. 50 Gy in 25 fractions over 5 weeks 2. 40 Gy

Sponsors

Saurabh Kumar
Lead Sponsor
Institute of Post Graduate Medical Education and Research Kolkata
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients willing to participate in the study with written informed consent 2 Age 18 years to 70 years 3 Sex Females 4 Known to be suffering from Histopathologically proved Carcinoma of Breast 5 Undergone Surgery (breast conservation surgery or modified radical mastectomy) and chemotherapy 6 Eligible for Chest wall or Whole breast radiotherapy with Regional nodal irradiation including supraclavicular nodal region as part of adjuvant treatment 7 Normal haematological parameters a Haemoglobin more than 10gm/dl (patients can be transfused before treatment to achieve this level) b Total leucocyte count more than 4,000/cu.mm OR ANC more than 1500 c Platelet count more than 1,00,000/cu.mm 8 Normal biochemical blood parameters like LFT KFT AST or AL T less than 3 X Upper Limit of Normal 9 Normal thyroid function and anti TPO antibody negative a Serum TSH 0.5 to 4.7 mU/L or mU/mL b Serum free T4 10.3-35 pmol/L or 0.8 to 2.7 ng/dL 10 ECOG performance status 0 to 2 11 Patient willing to come for follow up

Exclusion criteria

Exclusion criteria: 1 Patient who previously diagnosed with clinical or subclinical hypothyroidism. 2 Metastatic disease or Bilateral breast malignancy 3 No history of autoimmune thyroiditis or neck surgery 4 Previous history of synchronous or metachronous malignancy 5 Pregnant or Lactating women 6 Patients unable to provide subjective information. 7 Patients with collagen vascular disease or any severe uncontrolled comorbid condition which may alter treatment outcome

Design outcomes

Primary

MeasureTime frame
To determine the incidence of hypothyroidism in breast cancer patients receiving Supraclavicular irradiation.Timepoint: Follow up visit at 4 weeks,8 weeks then 3 monthly from the completion of radiotherapy till the end of study—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Amitabha Manna

IPGMER Kolkata

amitavamanna1965@gmail.com9433009577

Outcome results

None listed

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