| CTRI Number |
CTRI/2025/03/082216 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Developing Supportive Dentistry Program In Patients with Cancer Receiving Oral Chemotherapy |
|
Scientific Title of Study
|
Developing Supportive Dentistry Program To Enhance Quality Of Life Outcomes In Patients with Cancer Receiving Oral Chemotherapy |
| 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 Nakshatra Shetty |
| Designation |
PhD Scholar |
| Affiliation |
KMC Manipal |
| Address |
Department of Palliative Medicine and Supportive care, Shirdi Saibaba Block, KMC Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8904457083 |
| Fax |
|
| Email |
nakshatrasandesh1807@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Salins |
| Designation |
Professor and Head of the Department |
| Affiliation |
KMC Manipal |
| Address |
Department of Palliative Medicine and Supportive care, Shirdi Saibaba Block, KMC Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9969683669 |
| Fax |
|
| Email |
naveen.salins@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nakshatra Shetty |
| Designation |
PhD Scholar |
| Affiliation |
KMC Manipal |
| Address |
Department of Palliative Medicine and Supportive care, Shirdi Saibaba Block, KMC Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8904457083 |
| Fax |
|
| Email |
nakshatrasandesh1807@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, MAHE ,Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Nakshatra Shetty |
| Address |
Department of Palliative Medicine and Supportive Care, Kasturba Medical College, Manipal, Karnataka, India, 576104 |
| 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 Nakshatra Shetty |
Kasturba Medical College, Manipal |
Department of Palliative medicine and Supportive care, KMC, Manipal
Udupi
KARNATAKA |
8904457083
nakshatra.kmcmpl2023@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard oral care provided in the department of Medical oncology |
Every day, once a day, three months |
| Intervention |
Supportive dentistry interventions like Mouth wash, oil pulling, Dietary advise, scaling and root planning, topical oral analgesic, topical oral steroid |
Everyday, once a day, three months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants with histopathologically diagnosed cancer aged ≥18 years.
2 Participants on oral chemotherapy for at least 4 weeks at the time of the assessment.
3 Consenting to participate. |
|
| ExclusionCriteria |
| Details |
1 Participants with head and neck cancer undergoing radiotherapy or surgery.
2 Within 3 months of the intravenous chemotherapy for any cancer. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Supportive dentistry intervention to treat oral complications in patients undergoing oral chemotherapy |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of quality of life in patients undergoing oral chemotherapy |
2 years |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
28/04/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Scoping Review Protocol Approved by Indian Journal of Palliative care, not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Changes done in the objective: Also included Intravenous chemotherapy and oral as well as Intravenous chemotherapy along with Oral chemotherapy alone. which will be used in objective 2,3,4. Amendment has been put to the IEC and got IEC approval for the same. |