| CTRI Number |
CTRI/2009/091/001007 [Registered on: 10/12/2009] |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cohort Study |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
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 |
Scientific Title of Study
Modification(s)
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| REFCTRI-2009 001007 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Suparna Kanti Pal |
| Designation |
Post Graduate Traniee |
| Affiliation |
|
| Address |
Department of RT II, Christian Medical College Hospital
IDA scudder Rd
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282046 |
| Fax |
|
| Email |
suparna@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Subhashini John |
| Designation |
Prof. & HOD |
| Affiliation |
Department of Radiotherapy Unit-II, CMC Vellore |
| Address |
Department of Radiation Oncology,
Christian Medical college Hospital
IDA scudder Rd
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282046 |
| Fax |
|
| Email |
subha@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Subhashini John |
| Designation |
Prof. & HOD |
| Affiliation |
Dept of Radiotherapy Unit-II, CMC Vellore |
| Address |
Department of RT
CMC Hospital
IDA scudder Rd
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282046 |
| Fax |
|
| Email |
subha@cmcvellore.ac.in |
|
Source of Monetary or Material Support
Modification(s)
|
| INSTITUTIONAL FUNDING from Fluid Reserch Grant Fund Christian Medical college, Vellore |
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Suparna Kanti Pal |
| Address |
DEPARTMENT OF RADIOTHERAPY
CHRISTIAN MEDICAL COLLEGE & HOSPITAL
IDA SCUDDER RD VELLORE
632004 TN |
| Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suparna Kanti Pal |
Department OF Radiation Oncology |
Department of Radiation Oncology,CMC hospital-632004
Vellore
TAMIL NADU |
04162282046
suparna@cmcvellore.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board(Ethics Committee) CMC, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E032||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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
Not applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 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
Modification(s)
|
| Outcome |
TimePoints |
| 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 |
| Factors infuencing occurence of hypothyroidism |
at 1st, 2nd and 3rd follow up .[ 6 weeks, 19 weeks and 32 weeks following completion of radiotherapy] |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
16/12/2011 |
| Date of Study Completion (India) |
28/02/2013 |
| Date of First Enrollment (Global) |
16/12/2009 |
| Date of Study Completion (Global) |
28/02/2013 |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Pal SK, Das S, Isiah R, John S. Determining the Occurrence of Hypothyroidism Following Treatment With Radiation Therapy in Head and Neck Carcinoma Patients and the Associated Role of Risk Factors and Dose-Volume Histograms: A Prospective Study. Cureus. 2022;14(11):e31590 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |