| CTRI Number |
CTRI/2024/05/067984 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate oral and dental needs in treated head and neck cancer survivor participants |
|
Scientific Title of Study
|
A cross-sectional observational study to evaluate oral and dental needs in treated head and neck cancer survivors |
| 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 Madhura Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer ACTREC |
| Address |
Dental Services, RRS Ground Floor, Room No 31, ACTREC, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 Raigarh MAHARASHTRA 410210 India |
| Phone |
09096046257 |
| Fax |
|
| Email |
sharmamadhura10@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhura Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer ACTREC |
| Address |
Dental Services, RRS Ground Floor, Room No 31, ACTREC, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 Raigarh MAHARASHTRA 410210 India |
| Phone |
09096046257 |
| Fax |
|
| Email |
sharmamadhura10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhura Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer ACTREC |
| Address |
Dental Services, RRS Ground Floor, Room No-31, ACTREC, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 Raigarh MAHARASHTRA 410210 India |
| Phone |
09096046257 |
| Fax |
|
| Email |
sharmamadhura10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Tata Memorial Centre |
| Tata Memorial Hospital (TMH) Tata Memorial Centre |
|
|
Primary Sponsor
|
| Name |
Advanced Center for Cancer Treatment Research and Education in Cancer ACTREC Tata Memorial Center |
| Address |
Plot No. 1& 2, Sector 22
Kharghar, Navi Mumbai - 410210.
Maharashtra, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhura Sharma |
Advance Centre for Treatment Research and Education in Cancer (ACTREC) Tata Memorial Center |
Dental Services, RRS Ground Floor,Room No 31, ACTREC, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 Raigarh MAHARASHTRA |
09096046257
sharmamadhura10@gmail.com |
| Dr Madhura Sharma |
Tata Memorial Hospital (TMH) Tata Memorial Center |
Dental and Prosthetic Surgery Department, HBB Room No 217, TMH , Dr. E Borges Road, Parel, Mumbai - 400 012 India Mumbai MAHARASHTRA |
09096046257
sharmamadhura10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee III , TMC-ACTREC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consenting patients, 18 or more than 18 years of age, reporting in the Dental and Prosthetic Surgery Department at TMH and ACTREC for post-treatment follow-up check-ups will be enrolled in this study. The patients should have completed at least 1 year since the last dose of radiotherapy. |
|
| ExclusionCriteria |
| Details |
The patients refusing to provide consent for the study. Patients who have not completed one year of the HNC treatment. Patients reporting with recurrence and/or secondary malignancies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recording dental and oral dental treatment needs |
Single Time point
Post head and neck cancer treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
Single time point
Post head and neck cancer treatment |
|
|
Target Sample Size
|
Total Sample Size="360" Sample Size from India="360"
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)
|
15/06/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The head and neck cancer burden in India has increased substantially in recent times. The recent advances in treatment of cancer have led to increase in the survivorship. However, oral complications resulting from cancer and cancer therapies cause acute and late toxicities that may be underreported, underrecognized, and undertreated. With the increase in the life expectancy; the patient’s desire to have a optimal long-term oral health and general well-being. have also increased substantially. The oral and dental health status plays a very important role for maintaining a good quality of life assisting in mastication and swallowing of food. Although some of the acute oral toxicities of cancer therapies may be reduced, they remain essentially unavoidable. The complications associated with HNC treatment many a times lead to patients being dental cripples with inability to have a normal diet. Prevention and management are best provided via multidisciplinary health care teams, which must be integrated and communicate effectively in order to provide the best patient care in a coordinated manner at the appropriate time. This study plans to evaluate the probable long-term effects of HNC treatment on oral and dental health status in a tertiary health care center. The resultant conclusions will help in maintaining, treating and rehabilitating HNC patients for dental professionals. |