| CTRI Number |
CTRI/2024/04/066221 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Prospective observational study to assess the shoulder morbidity and the role of physiotherapy in oral cancer patients |
|
Scientific Title of Study
|
To Evaluate and Assess Shoulder Morbidity using Constant Murley score after Neck Dissection in Oral Cancer Patients- A Prospective Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Joshi |
| Designation |
Professor and Head Neck Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
Head and Neck department room no 266 paymaster shodhika Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9769143523 |
| Fax |
|
| Email |
drpoonamjoshitmh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Joshi |
| Designation |
Professor and Head Neck Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
Head and Neck department room no 266 paymaster shodhika Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
9769143523 |
| Fax |
|
| Email |
drpoonamjoshitmh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Joshi |
| Designation |
Professor and Head Neck Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
Head and Neck department room no 266 paymaster shodhika Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
9769143523 |
| Fax |
|
| Email |
drpoonamjoshitmh@gmail.com |
|
|
Source of Monetary or Material Support
|
| No funding required as prospective observational study
address advanced Centre for treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Rd Owe Camp Kharghar Navi Mumbai Maharashtra 410210
|
|
|
Primary Sponsor
|
| Name |
advanced Centre for treatment Research and Education in Cancer |
| Address |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 |
| 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 Poonam Joshi |
Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre |
Head neck surgical
oncology department
paymaster shodhika
2nd floor room no 266
Sector 22 Utsav Chowk
CISF Road Owe Camp
Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
9769143523
drpoonamjoshitmh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer Institutional Ethics Committee (TMC-IEC III) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Treatment naïve Oral cavity cancer patients who require surgery at our Centre
-Patients who are agreeable for physiotherapy exercises.
-Patients who will adhere for 6 months of follow up post treatment.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Composite value of Constant Murley score. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient reported outcome using the University of Washington Quality of Life UW-QOL assessment |
2 years |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
05/05/2025 |
| 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
|
Surgery
is considered as the mainstay treatment modality for Oral squamous cell
carcinoma (OSCC) patients. Elective
neck dissection is now the current standard of care in early management of these
patients. However, functional disability is observed in these patients in terms
of shoulder morbidity.
With the help of a validated
‘Constant Murley Score’ we would like to evaluate and assess
Shoulder problems
in Oral cavity cancer patients treated at our Centre prospectively. We aim to
evaluate exactly the shoulder morbidity caused after neck surgery and compare
it with pre-operative assessment. We also wish to understand the effect
of physiotherapy on shoulder dysfunction in these patients.
Therefore, through this prospective study we desire
to quantitatively assess the shoulder morbidity and the role of physiotherapy.
This will be helpful in truly understanding the morbidity associated with neck
dissection in oral cancer patients. |