Role of Vit-D deficiency in Head and Neck Cancer.

Not yet recruiting

• Conditions: Malignant neoplasm of mouth, unspecified,

• Registration Number: CTRI/2020/01/023049
• Lead Sponsor: TATA MEMORIAL HOSPITAL

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-02
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 561

Inclusion Criteria

• Newly diagnosed, treatment naïve HNSCC patients.
• Undergoing upfront surgery followed by adjuvant treatment (as indicated).
• Willing to follow up in TMH.

Exclusion Criteria

• Recurrent cancer & Second Primary.
• Nasopharyngeal carcinoma, metastasis of unknown origin.
• Patients not giving consent for the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Disease free survival.	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.
-Overall survival.	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.
-Prevalence of vitamin D deficiency.	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.
-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 Measures

Name	Time	Method
-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.

Trial Locations

Locations (1)

TATA MEMORIAL HOSPITAL; 🇮🇳 Mumbai, MAHARASHTRA, India

TATA MEMORIAL HOSPITAL

🇮🇳Mumbai, MAHARASHTRA, India

Dr SHIVAKUMAR THIAGARAJAN

Principal investigator

9846572399

drshiva78in@gmail.com