| CTRI Number |
CTRI/2020/01/023049 [Registered on: 30/01/2020] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Vit-D deficiency in Head and Neck Cancer. |
|
Scientific Title of Study
|
Prevalence and impact of Vitamin D deficiency on the treatment outcomes of Head and Neck squamous cell carcinoma patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHIVAKUMAR THIAGARAJAN |
| Designation |
Assistant Professor & Surgeon, MS(ENT)DNB, Department of Head & Neck Surgical Oncology |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
1209 Homi Bhabha Block TaTa Memorial Hospital Dr. Ernest
Borges Marg Parel Mumbai-400012 Office 02224177000 Extn 6656.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9846572399 |
| Fax |
|
| Email |
drshiva78in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHIVAKUMAR THIAGARAJAN |
| Designation |
assistant professor, MS(ENT)DNB,Department of Head and Neck Surgical Oncology E, |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
1209 Homi Bhabha Block Tata Memorial Hospital Dr. Ernest
Borges Marg Parel Mumbai-400012 Office 02224177000 Extn 6656.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9846572399 |
| Fax |
|
| Email |
drshiva78in@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHIVAKUMAR THIAGARAJAN |
| Designation |
Assistant Professor,MS(ENT)DNB, Department Of Head and Neck Surgical Oncology E |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
1209 Homi Bhabha Block Tata Memorial Hospital Dr. Ernest
Borges Marg Parel Mumbai-400012 Office 02224177000 Extn 6656.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9846572399 |
| Fax |
|
| Email |
drshiva78in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Dr. Ernest
Borges Marg Parel Mumbai-400012 Office 02224177000 |
|
|
Primary Sponsor
|
| Name |
TATA MEMORIAL HOSPITAL |
| Address |
Dr. Ernest Borges Marg, Parel,Mumbai 400012,India Phone 9122-24177000 |
| Type of Sponsor |
Other [Investigator Initiated Study] |
|
|
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 SHIVAKUMAR THIAGARAJAN |
TATA MEMORIAL HOSPITAL |
Dr. Ernest Borges Marg
Parel Mumbai 400012,
Office 02224177000
Mumbai
Mumbai
MAHARASHTRA |
9846572399
drshiva78in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Newly diagnosed, treatment naïve HNSCC patients.
-Undergoing upfront surgery followed by adjuvant treatment (as indicated).
-Willing to follow up in TMH. |
|
| ExclusionCriteria |
| Details |
-Recurrent cancer & Second Primary.
-Nasopharyngeal carcinoma, metastasis of unknown origin.
-Patients not giving consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Disease free survival.
-Overall survival.
-Prevalence of vitamin D deficiency.
-Quality of life using FACT HN score. |
Vitamin D deficiency in the patients will be corrected with standard treatment protocol.
- Patients QOL will be accessed, prior to treatment, at treatment completion & at 1yr follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -To know the role of vitamin D deficiency in the pathophysiology of squamous cell carcinoma of Head and Neck and throw light on the treatment outcome. |
Vitamin D deficiency in the patients will be corrected in due course with standard treatment protocol.
- Patients QOL will be accessed, prior to treatment, at treatment completion & at 1yr follow-up. |
|
|
Target Sample Size
|
Total Sample Size="561"
Sample Size from India="561"
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)
|
01/02/2020 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study intends to see the prevalence of Vitamin D deficiency and its impact on the treatment outcomes in head and neck squamous cell carcinoma patients. As Vitamin D deficiency has been shown to be associated with various cancers in the literature and there are studies to show the protective role of Vitamin D against cancers in view of its immunomodulatory action. This study will determine whether such an association is present in our population of head and neck cancers. And if so, we can preemptively start treating Vitamin D deficiency in our patients.
|