| CTRI Number |
CTRI/2025/09/095480 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of exercise in improving radiation induced side effects in head and neck cancer. |
|
Scientific Title of Study
|
Role of exercise in improving radiation induced long term side effects in head and neck cancer. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Upadhyay |
| Designation |
Assistant Professor |
| Affiliation |
Shri Ram Murti Samark Institute Of Medical Scienes |
| Address |
RR Cancer Centre Radiation oncology Department Shri Ram Murti Smarak Institute Of Medical Science Hospital Bhojpura Bareilly
Bareilly
UTTAR PRADESH
243202
India
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8826004576 |
| Fax |
|
| Email |
prachiupadhyay20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prachi Upadhyay |
| Designation |
Assistant Professor |
| Affiliation |
Shri Ram Murti Samark Institute Of Medical Scienes |
| Address |
RR Cancer Centre Radiation oncology Department Shri Ram Murti Smarak Institute Of Medical Science Hospital Bhojpura Bareilly
Bareilly
UTTAR PRADESH
243202
India
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8826004576 |
| Fax |
|
| Email |
prachiupadhyay20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Upadhyay |
| Designation |
Assistant Professor |
| Affiliation |
Shri Ram Murti Samark Institute Of Medical Scienes |
| Address |
RR Cancer Centre Radiation oncology Department Shri Ram Murti Smarak Institute Of Medical Science Hospital Bhojpura Bareilly
Bareilly
UTTAR PRADESH
243202
India
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8826004576 |
| Fax |
|
| Email |
prachiupadhyay20@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRMS IMS Bhojipura Bareilly Uttar Pradesh India 243202 |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
SRMS IMS HOSPITAL
NAINITAL-BAREILLY ROAD
BHOJIPURA
BAREILLY
UTTAR PRADESH |
| Type of Sponsor |
Private 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 PRACHI UPADHYAY |
SRMS IMS |
RR CANCER RESERACH CENTRE SRMS IMS
BHOJIPURA
BAREILLY
UTTAR PRADESH
PIN CODE 243202
Bareilly
UTTAR PRADESH |
8826004576
prachiupadhyay20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMS IMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neck Exercise Protocol |
Exercises:
Neck flexion/extension, lateral flexion, and rotation
Neck retraction/posture correction
Isometric neck strengthening
Home Program: Daily 30 minutes of prescribed neck exercises
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All Histologically confirmed head and neck cancer, Completion of radiotherapy (± chemotherapy) within the last 4 weeks with ECOG 0–2 ,Able and willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
Recurrent/metastatic disease,Neurological disorders affecting the neck,Orthopaedic limitations preventing neck movement,Severe cognitive impairment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of neck exercises on cervical ROM, fatigue, and quality of life in HNC patients post-radiotherapy. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess changes in neck-related facial oedema and pain,To evaluate the feasibility and adherence of a neck exercise protocol
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
13/10/2025 |
| 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="2"
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
|
to evaluate whether introducing neck exercise protocol in head and neck cancer survivor improve physical function and overall well being or whether it promote faster return to daily activities and social participants. |