| CTRI Number |
CTRI/2019/05/019063 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
11/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the rate of Hypothyroidism in patients of Head and Neck Cancer receiving Radiotherapy amongst the people of North East India |
|
Scientific Title of Study
|
Incidence of Hypothyroidism in Patients of Head and Neck Cancer Receiving External Beam Radiotherapy amongst the People of North East India |
| Trial Acronym |
BBCIRT03 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Biswajit Sarma |
| Designation |
Post Graduate Trainee |
| Affiliation |
Dr. B Borooah Cancer Instute, Guwahati |
| Address |
OPD Number 12
Dr. B Borooah Cancer Institute
Gopinath Nagar, Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
9085063653 |
| Fax |
|
| Email |
drbiswasarma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apurba Kumar Kalita |
| Designation |
Prof & HOD Department of Radiation Oncology |
| Affiliation |
Dr. B Borooah Cancer Instute |
| Address |
OPD No 12
Dr. B Borooah Cancer Institute
Gopinath Nagar, Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
9864035015 |
| Fax |
|
| Email |
akkalita@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biswajit Sarma |
| Designation |
Post Graduate Trainee |
| Affiliation |
Dr. B Borooah Cancer Instute |
| Address |
OPD Number 12
Dr. B Borooah Cancer Institute
Gopinath Nagar, Guwahati
Kamrup
ASSAM
781026
India |
| Phone |
9085063653 |
| Fax |
|
| Email |
drbiswasarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B Borooah Cancer Institute |
| self financed |
|
|
Primary Sponsor
|
| Name |
Dr Biswajit Sarma |
| Address |
OPD No 12
Dr. B Borooah Cancer Institute
Gopinath Nagar,Guwahati |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Biswajit Sarma |
Dr B Borooah Cancer Institute |
BBCI
Gopinath Nagar
Guwahati
pin 781016
Kamrup
ASSAM |
9085063653
drbiswasarma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BBCI Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C138||Malignant neoplasm of overlappingsites of hypopharynx, (2) ICD-10 Condition: C108||Malignant neoplasm of overlappingsites of oropharynx, (3) ICD-10 Condition: C118||Malignant neoplasm of overlappingsites of nasopharynx, (4) ICD-10 Condition: C008||Malignant neoplasm of overlappingsites of lip, (5) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (6) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, (7) ICD-10 Condition: C131||Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect, (8) ICD-10 Condition: C098||Malignant neoplasm of overlappingsites of tonsil, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Karnoffskys performance score >70.
Biopsy proven carcinoma of head and neck.
Head and neck cancer receiving radical radiotherapy.
Stage I, II, III, IVa. |
|
| ExclusionCriteria |
| Details |
no history of prior thyroid dysfunction before starting treatment or no history of taking any kind of thyroid hormone medication
any distant metastasis
prior irradiation, surgery, chemotherapy to head and neck area
patients with serious co-morbidities like myocardial infarction, chronic kidney disease, diabetes mellitus, cns disorders, disorders of GI tract, hepatobiliary tract or other significant cardiac disease
previous history of malignancy or co existing malignancy of any other part
Inability to sign consent from |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the incidence of hypothyroidism in patients of head and neck cancer receiving external beam radiation therapy |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| this study will help in diagnosing hypothyroidism at an early state |
till patient comes for follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/05/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not available at present |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study I will assess the incidence of Hypothyroidism in patients of head and neck cancer receiving external beam radiotherapy. A tertiary hospital based single institutional study in North East India |