| CTRI Number |
CTRI/2024/10/075945 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
New Treatments for Mouth Cancer: Using Nanotechnology and Iron Targeting in Clinical Trials |
|
Scientific Title of Study
|
Risk stratification and advancing precision therapy strategies for Oral Squamous Cell Carcinoma (OSCC) through the integration of Nanotechnology-enhanced Nutritional interventions with comprehensive Randomized controlled Trials: Exploring the Therapeutic potential of targeting Iron-Responsive Elements (IREs) and their binding proteins. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hema Shree K |
| Designation |
Research scholar, MDS Oral Pathology |
| Affiliation |
Saveetha Dental College, SIMATS |
| Address |
Department of Oral pathology,
Saveetha Dental College,
SIMATS,
Chennai-77
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994975670 |
| Fax |
|
| Email |
hemashree9111990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hema Shree K |
| Designation |
Reseach scholar, MDS Oral Pathology |
| Affiliation |
Saveetha Dental College, SIMATS |
| Address |
Department of Oral Pathology, Saveetha Dental College,
SIMATS,
Velappanchavadi,
Chennai-77
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994975670 |
| Fax |
|
| Email |
hemashree9111990@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hema Shree K |
| Designation |
Research scholar, MDS Oral Pathology |
| Affiliation |
Saveetha Dental College, SIMATS |
| Address |
Department of Oral Pathology,
Saveetha Dental College,
SIMATS,
Chennai-77
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994975670 |
| Fax |
|
| Email |
hemashree9111990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research- DHR(Department of Health Research)grant applied under Womens Fellowship, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research DHRDepartment of Health Research New Delhi India |
| Address |
Indian Council of Medical Research- DHR(Department of Health Research)grant applied under Womens Fellowship, New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Pratibha Ramani |
Saveetha Dental college, SIMATS, Chennai |
Clinic 29, Department of Oral Pathology, Saveetha Dental College, SIMATS, Chennai-77
Thiruvallur
TAMIL NADU |
9994975670
hemashree9111990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
completely healthy |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nano-Iron |
Iron nano supplement for control group |
| Intervention |
Nano-Iron |
The supplement, containing iron nanoparticles and essential nutrients, aims to disrupt tumor iron metabolism, inhibiting cancer cell growth. Participants will receive a daily oral dose of 10 mg once daily for 12 months, with regular monitoring and dietary counseling. A placebo-controlled, double-blind design ensures unbiased results. The control group will receive a matching placebo. Follow-up assessments will occur every 3 months during treatment and every 6 months post-treatment for up to 3 years. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Non habit OSCC patients and healthy individuals |
|
| ExclusionCriteria |
| Details |
patient without habits |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall Survival (OS), Progression-Free Survival (PFS) will be assessed at regular time intervals at baseline, 3rd month, 6 th month, 9th month and 12 th month |
Overall Survival (OS), Progression-Free Survival (PFS) will be assessed at regular time intervals at baseline, 3rd month, 6 th month, 9th month and 12 th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Response Rate (RR), Quality of Life (QoL),Biomarker Response,
Safety and Tolerability
|
3 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/01/2025 |
| 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="3"
Months="0"
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 - NO
|
|
Brief Summary
|
Oral Squamous Cell Carcinoma (OSCC) remains a significant global health challenge due to its aggressive nature and poor prognosis in advanced stages. Traditional therapeutic approaches often fall short in effectively addressing the heterogeneity and complexity of OSCC. To improve outcomes, there is a pressing need for strategies that offer precise risk stratification and tailored therapeutic interventions. The trial seeks to advance precision therapy for OSCC by integrating cutting-edge nanotechnology-enhanced nutritional interventions within the framework of comprehensive randomised controlled trials (RCTs). Specifically, the trial will explore the therapeutic potential of targeting Iron-Responsive Elements (IREs) and their binding proteins, which play a critical role in cellular iron metabolism and have been implicated in cancer progression. By focusing on these molecular targets, the trial aims to develop more effective, personalized treatment strategies that could lead to better management and prognosis of OSCC. |