A prospective study to determine the occurrence of hypothyroidism following treatment with radiation therapy in patients of head and neck carcinomas(cancers) and the influencing factors
- Conditions
- Health Condition 1: E032- Hypothyroidism due to medicamentsand other exogenous substancesHealth Condition 2: null- Incidence of clinical and subclinical hypothyroidism in patients undergoing radiation for head and neck carcinomasHealth Condition 3: C00-C14- Malignant neoplasms of lip, oral cavity and pharynxHealth Condition 4: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2009/091/001007
- Lead Sponsor
- Dr Suparna Kanti Pal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1.Adult patients[ more than 18 years of age] with non-metastatic Head & Neck carcinoma, without any intracranial extension, of the following sites-
a.Nasopharynx
b.Sinonasal cavity
c.Oropharynx
d.Oral cavity
e.Hypopharynx
f.Larynx
g.CUP [Carcinoma of unknown primary]
2.Patients receiving radiotherapy( >45 Gy) as part of treatment
3.Radiation field extending to lower neck , unilateral or bilateral
4.Performance score- 0 to 2
11.Known to have hypothyroidism
a)At the time of screening
b) The history of hypothyroidism in the past, for which he/she is currently on supplements. [Hypothyroidism was defined as TSH more than the maximum of the normal range, or TSH >4.5 micro IU/ml].
2.Who has a history of previous exposure to radiation therapy in Head and neck region
3.Carcinomas with intracranial extension by clinical or radiological examination
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HypothyroidsimTimepoint: At the time of follow up. 1st, 2nd and 3rd follow up [6 weeks, 19 weeks, 32 weeks post completion of radiotherapy] and or at the last available follow up
- Secondary Outcome Measures
Name Time Method Factors infuencing occurence of hypothyroidismTimepoint: at 1st, 2nd and 3rd follow up .[ 6 weeks, 19 weeks and 32 weeks following completion of radiotherapy];Impact of devolopment of iatrogenic hypothyroidism on quality of lifeTimepoint: at end of radiotherapy and at 1st, 2nd, 3rd follow up and at last follow up