| CTRI Number |
CTRI/2024/08/071788 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Radiation Dose to Mastication Muscles Correlation with mouth opening in post op oral cancers |
|
Scientific Title of Study
|
Radiation Dose Received by Muscles of Mastication and its Correlation with Degree of Trismus in Post-Operative Cases of Buccal Mucosa Cancers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Mukherji |
| Designation |
Professor and Head of Department |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Office of Head of Department, Department of Radiation Oncology, MPMMCC, Varanasi, Uttar Pradesh 221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9489146747 |
| Fax |
|
| Email |
drashutoshm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasenjit Nath |
| Designation |
Junior Resident |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Radiation Oncology, MPMMCC and HBCH,
Varanasi, Uttar Pradesh 221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9556773763 |
| Fax |
|
| Email |
rimunnath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Mukherji |
| Designation |
Professor and Head of Department |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Office of Head of Department, Radiation Oncology, MPMMCC and HBCH, Varanasi, Uttar Pradesh 221005 India
UTTAR PRADESH
221005
India |
| Phone |
9489146747 |
| Fax |
|
| Email |
drashutoshm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study done at Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundar Bagiya, Near Naria Gate, BHU Campus, Varanasi, Uttar Pradesh India 221005. No funding requested |
|
|
Primary Sponsor
|
| Name |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
| Address |
Sundar Bagiya, Near Naria Gate, BHU Campus, Varanasi, Uttar Pradesh India 221005. |
| 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 Ashutosh Mukherji |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
Office of Head of Department, Department of Radiation Oncology, Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital,Sundar bagiya, BHU Campus, Naria gate, Varanasi,
Varanasi
UTTAR PRADESH |
9489146747
drashutoshm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven squamous cell carcinoma of buccal mucosa.
Age 18 to 70 years
Both sexes
Karnofsky performance status 70 or above
Adequate surgical resection of primary and nodal disease
Nonmetastatic disease.
Patients planned for adjuvant chemoradiation or adjuvant radiotherapy only with dose of RT ranging from 60 to 64Gy in 30 to 32 fractions by VMAT
Only patients having Maximal Inter Incisal Opening more than 25mm at the time of RT starting will be included.
In patients with no Incisors teeth, Inter alveolar distance will be considered. |
|
| ExclusionCriteria |
| Details |
Any histopathology other than SCC
Previous radiotherapy to the head and neck region
Synchronous or metachronous malignancy
Maximal Inter Incisal Opening less than 25mm at the time of RT starting
Pregnant or lactating women
Evidence of distant metastasis
Recurrent or residual disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the correlation between the dose-volume parameters of the muscles of
mastication, temporo- mandibular joint and the degree of trismus developed post radiotherapy in post-operative buccal mucosa cancers. |
to be assessed 1 month and 3 months Post radiation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Acute toxicities as per RTOG criteria to be assessed 1 month and 3 months Post RT.
2. Assessment of dose received by back of neck and subcutaneous tissue toxicity grading as per RTOG at 3 months, 6 months and 1-year Post-RT. |
to be assessed 1 month and 3 months Post RT. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
16/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/08/2024 |
| 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 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
|
We aim to study difficulty in mouth opening in operated cases of buccal mucosa undergoing Radiotherapy with or without Chemotherapy. We will collect the dose received to the muscles of mastication and TMJ by delineating them on the planning CT scan. We will assess the degree of trismus or mouth opening by measuring the distance between upper and lower central incisor teeth. We will observe the correlation between the radiation dose received by the muscles of mastication and temporo-mandibular joints of both sides and degree of trismus caused by it. Data will be collected as interincisal/interalveolar distance of patients during routine follow up periods and the dose received by the muscles of mastication and TMJ. |