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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

A prospective study to determine the occurrence of hypothyroidism following treatment with radiation therapy in patients of head and neck carcinomas and the influencing factors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2009/091/001007
Enrollment
80
Registered
2009-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: E032- Hypothyroidism due to medicamentsand other exogenous substances Health Condition 2: null- Incidence of clinical and subclinical hypothyroidism in patients undergoing radiation for head and neck carcinomas Health Condition 3: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 4: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: Not applicable

Sponsors

Dr Suparna Kanti Pal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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;Factors infuencing occurence of hypothyroidismTimepoint: at 1st, 2nd and 3rd follow up .[ 6 weeks, 19 weeks and 32 weeks following completion of radiotherapy]

Countries

India

Contacts

Public ContactDr Subhashini John

Department of Radiotherapy Unit-II, CMC Vellore

subha@cmcvellore.ac.in04162282046

Outcome results

None listed

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