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

Completed

• Conditions: Hypothyroidism due to medicamentsand other exogenous substances, Incidence of clinical and subclinical hypothyroidism in patients undergoing radiation for head and neck carcinomas, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (3) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,

• Registration Number: CTRI/2009/091/001007
• Lead Sponsor: Dr Suparna Kanti Pal

Brief Summary

The cohort study would include study population who are undergoing radiotherapy to the neck region for head and neck carcinomas. We would determine clinical and biochemical status with respect to thyroid function, before starting of radiotherapy (as a screening test), at the follow ups,1st follow up and up to 3rd follow up (from 6 weeks to about 7.5 months[32 weeks] of completion of radiation treatment) and then as required. The 1st of these i.e., the one before starting radiotherapy would also act as screening test for inclusion into the study.

The patients would be classified as per demographic parameters (age, sex, place of domicile), sub site of the disease, surface dose to thyroid region, treatment co- factors, (concurrent chemotherapy and surgery with unilateral and bilateral MRND) and other factors if any. surface point dose measurement of the region of thyroid gland would be done during treatment using a diode or TLD for patients who undergo conventional radiotherapy. The dosimetric data [ including DVH] obtained form the Treatment Planning system [TPS- Plato / Eclipse/ Oncentra] would be used for estimating dose received in case of patients undergoing 3DCRT or IMRT/ IGRT.

Anybody found to have hypothyroidism at the time of screening would not be included for further evaluation. If a patient who after inclusion in the study develops subclinical or clinical hypothyroidism would be referred to endocrinology for the management of the same. Such patients are considered to have reached end point. Once the study is complete, the available data would then be analysed and tabulated with respect to occurrence of hypothyroidism and the results would then be analysed for significance of the factors.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Study Completion: 2013-02-28
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

• 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 region3.Carcinomas with intracranial extension by clinical or radiological examination.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypothyroidsim	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 hypothyroidism	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 life	at end of radiotherapy and at 1st, 2nd, 3rd follow up and at last follow up

Trial Locations

Locations (1)

Department OF Radiation Oncology; 🇮🇳 Vellore, TAMIL NADU, India

Department OF Radiation Oncology

🇮🇳Vellore, TAMIL NADU, India

Dr Suparna Kanti Pal

Principal investigator

04162282046

suparna@cmcvellore.ac.in