| CTRI Number |
CTRI/2026/03/105530 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Occurrence and Risk Factors of Post-Radiotherapy Trismus in Oral Cavity Cancer Patients |
|
Scientific Title of Study
|
“A Prospective study to assess the occurrence and factors causing trismus in patients with oral Cavity cancers Post Radiotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Bowjenku |
| Designation |
MD Radiotherapy junior resident (1st year) |
| Affiliation |
Sri Venkateshwara Institute of Medical Sciences |
| Address |
Department Of Radiation oncology
Sri Venkateshwara Institute of Medical Sciences
Alipri road
Tirupati
Chittoor
ANDHRA PRADESH
517507
India
Department Of Radiation oncology
Sri Venkateshwara Institute of Medical Sciences
Alipri road
Tirupati
Chittoor
ANDHRA PRADESH
517507
India
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9866897542 |
| Fax |
|
| Email |
Priyasweetie.0105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRBV SUBRAMANIAN |
| Designation |
MD Radiotherapy HOD Senior professor |
| Affiliation |
Sri Venkateshwara Institute of Medical Sciences |
| Address |
Department of Radiation oncology
Sri Venkateshwara Institute of Medical Sciences
Alipri road
Tirupati
Chittoor
ANDHRA PRADESH
517507
India
Department of Radiation oncology
Sri Venkateshwara Institute of Medical Sciences
Alipri road
Tirupati
Chittoor
ANDHRA PRADESH
517507
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9849692950 |
| Fax |
|
| Email |
ravibalasubramanian@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya Bowjenku |
| Designation |
MD Radiotherapy junior resident (1st year) |
| Affiliation |
Sri Venkateshwara Institute of Medical Sciences |
| Address |
Department Of Radiation oncology
Sri Venkateshwara Institute of Medical Sciences
Alipri road
Tirupati
Chittoor
ANDHRA PRADESH
517507
India
Department Of Radiation oncology
Sri Venkateshwara Institute of Medical Sciences
Alipri road
Tirupati
Chittoor
ANDHRA PRADESH
517507
India
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9866897542 |
| Fax |
|
| Email |
Priyasweetie.0105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Radiation oncology Sri Venkateswara Institute of Medical Sciences Alipri road Tirupati 517507 Andhra pradesh India |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwara Institute of Medical Sciences |
| Address |
Department Of Radiation oncology Sri Venkateswara Institute of Medical Sciences Alipri road Tirupati 517507 Andhra pradesh India |
| Type of Sponsor |
Other [self] |
|
|
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 Priya Bowjenku |
Sri VenkatesHwara Institute of Medical Sciences |
Department Of Radiation oncology
Sri VenkatesHwara Institute of Medical Sciences
Alipri road Tirupati 517507
Chittoor
ANDHRA PRADESH
Chittoor
ANDHRA PRADESH |
9866897542
Priyasweetie.0105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| insititute of medical ethic committe sri venkateshwara institute of medical science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
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 |
1.Histo-pathologically proven squamous cell carcinoma [SCC] of oral and oropharyngeal cancers
2.Age : 18 -70 years .
3.Patients with eastern cooperative oncology group [ECOG] performance status of 0-2
4.Stage I to IV B SCC of oral cavity cancers [American joint committee on cancer : 8th edition
5. Patients treated with surgery
|
|
| ExclusionCriteria |
| Details |
1.Cancer with distant metastasis.
2.Patient with ECOG performance status of 3-4.
3.Patients previously treated with radiotherapy to head & neck region.
4.Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess occurrence of trismus in oral cavity |
three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess contributing risk factors in development of trismus |
three months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response (Others) - NIL
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 25-03-2026 and end date provided 03-03-2027?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective, single-center observational cohort study conducted at SVIMS, Tirupati, aims to evaluate the occurrence of trismus in patients with oral cavity squamous cell carcinoma treated with radiotherapy, with or without concurrent chemotherapy. The study assesses clinical, tumor-related, and treatment-related factors contributing to post-radiotherapy trismus. Patients undergo detailed pretreatment evaluation, standardized radiotherapy planning using VMAT, and structured follow-up. Trismus is graded using CTCAE criteria, and statistical analysis is performed with SPSS to determine significant risk factors. Ethical approval, informed consent, and CTRI registration are ensured for regulatory compliance
|