跳至主要内容
临床试验/CTRI/2021/05/033534
CTRI/2021/05/033534尚未招募不适用

Hypothyroidism following definite radiotherapy in patients with head and neck cancer; prospective observational study

Indira Gandhi Medical College Shimla1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月17日最近更新:

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
incidence of radiation induced hypothyroidism

研究概览

简要总结

Head and neck cancers are one of the common cancers seen in state of Himachal Pradesh. The treatment consists of surgery and radiotherapy with or without chemotherapy. Definitive radiotherapy for head and neck cancer results in radiation of exposed part of Thyroid gland. The reported prevalence of incident hypothyroidism varies from17 to 47%9. The variability of radiation induced hypothyroidism could be related to varied dose of radiation, volume of thyroid gland exposed, ethnicity, geographical conditions related to iodine contend of the soil, endemicity of hypothyroidism, autoimmune status of the individuals. Development of hypothyroidism carries the risk of  poor wound healing and recovery. Therefore determining the radiation induced hypothyroidism and it’s risk determinants in our patient population is of great importance in developing informed protocols for screening and early detection of high risk patients of head and neck cancers following definitive radiotherapy to reduce morbidity.The contemporary data on radiation induced hypothyroidism and risk factors in patients with head and neck cancers undergoing definitive radiotherapy is limited to develop evidence based screening protocol for detection of radiation induced hypothyroidism.Thus we propose to determine the incidence of hypothyroidism and its risk factors among patients of head and neck cancer undergoing definitive radiotherapy free of hypothyroidism at baseline in prospective observational study. The findings of the study would help in developing evidence based protocol for screening high risk patients for radiation induced hypothyroidism using the limited resources rationally.

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
All

入选标准

  • a.all consecutive patients of head and neck confirmed on histopathology visiting regional cancer centre of IGMC planned to undergo definitive radiotherapy and who are free of hypothyroidism at base line consenting to participate following informed consent would be enrolled in the study.
  • The subsites included will be oral cavity, oropharynx, hypo-pharynx and larynx .

排除标准

  • Patients with hypothyroidism at base line and patients who are not been treated with curative intent.

结局指标

主要结局

incidence of radiation induced hypothyroidism

时间窗: At base line and one year after completion of radiotherapy

次要结局

  • To identify risk factors for radiation induced hypothyroidism

研究者

发起方
Indira Gandhi Medical College Shimla
申办方类型
Government medical college

研究点 (1)

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