Prospective Study on Assessment of Thyroid Function in Breast Cancer patients receiving supraclavicular radiation therapy as a part of adjuvant therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine the incidence of hypothyroidism in breast cancer patients receiving Supraclavicular irradiation.
研究概览
简要总结
The study is anticipated to yield the following key results
Incidence Data Quantitative assessment of how frequently hypothyroidism (clinical or subclinical) occurs post supraclavicular radiotherapy in breast cancer patients.
Time Course Identification of the onset period whether acute (within weeks) or delayed (months to years) of hypothyroidism.
Dose-Response Relationship Correlation between radiation dose to the thyroid gland and the likelihood of hypothyroidism, helping to establish a threshold dose.
Risk Stratification Recognition of clinicopathological factors that increase susceptibility to hypothyroidism.
Clinical Recommendations Proposal for routine thyroid function tests (e.g., TSH, free T4) before and after radiotherapy at defined intervals, Tailored follow-up schedules for high-risk individuals, risk-adapted modifications in radiation planning to minimize thyroid exposure and finally to render improved survivorship care.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To determine the incidence of hypothyroidism in breast cancer patients receiving Supraclavicular irradiation.
时间窗: Follow up visit at 4 weeks,8 weeks then 3 monthly from the completion of radiotherapy till the end of study
次要结局
未报告次要终点
研究者
Saurabh Kumar
IPGMER Kolkata