| CTRI Number |
CTRI/2021/05/033534 [Registered on: 11/05/2021] Trial Registered Prospectively |
| Last Modified On: |
10/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hypothyroidism following radiotherapy in patients with head and neck cancer. |
|
Scientific Title of Study
|
Hypothyroidism following definite radiotherapy in patients with head and neck cancer; prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddharth Vats |
| Designation |
Associate Professor |
| Affiliation |
IGMC Shimla |
| Address |
Room no. 23, 3rd floor, TCCC , IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418458100 |
| Fax |
|
| Email |
drsiddharthvats@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siddharth Vats |
| Designation |
Associate Professor |
| Affiliation |
IGMC Shimla |
| Address |
Room no. 23, 3rd floor, TCCC , IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418458100 |
| Fax |
|
| Email |
drsiddharthvats@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddharth Vats |
| Designation |
Associate Professor |
| Affiliation |
IGMC Shimla |
| Address |
Room no. 23, 3rd floor, TCCC , IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418458100 |
| Fax |
|
| Email |
drsiddharthvats@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College Shimla |
| Address |
Member Secretary, Institutional Ethics Committee, IGMC Shimla |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shabnum Thakur |
IGMC Shimla |
Room no. 23 , third floor, Tertiary care cancer hospital, IGMC Shimla
1771001
Shimla
HIMACHAL PRADESH |
9459830966
thakurshabnum7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IGMC Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C090||Malignant neoplasm of tonsillar fossa, (3) ICD-10 Condition: C052||Malignant neoplasm of uvula, (4) ICD-10 Condition: C100||Malignant neoplasm of vallecula, (5) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (6) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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 .
|
|
| ExclusionCriteria |
| Details |
Patients with hypothyroidism at base line and patients who are not been treated with curative intent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of radiation induced hypothyroidism |
At base line and one year after completion of radiotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify risk factors for radiation induced hypothyroidism
|
At base line and one year after completion of radiotherapy |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/05/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
n/a |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |