Desmostachya Bipinnata Platinum Patch for Oral Ulcers in Cancer Therapy

Not yet recruiting

• Conditions: Malignant neoplasm of mouth, unspecified,

• Registration Number: CTRI/2025/04/084509
• Lead Sponsor: Department of Health Research

Brief Summary

We are conducting this study to develop an **effective, plant-based nanomedicine** for managing **chemotherapy-induced oral mucositis**, a painful and debilitating condition that significantly impacts cancer patients’ **quality of life, nutrition, and treatment adherence**. Current treatments provide **limited relief** and often have **side effects**, necessitating **a safer, more effective alternative**. The **Db platinum mucoadhesive patch** integrates **Desmostachya bipinnata-derived phytochemicals with platinum nanoparticles**, offering **anti-inflammatory, wound-healing, and antimicrobial properties**. This study aims to assess its **efficacy in reducing mucositis severity, pain, and microbial load**, while improving **oral healing and patient comfort**, ultimately enhancing **clinical outcomes in cancer care**.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients aged 30 years and above, diagnosed with oral squamous cell carcinoma (OSCC) and operated for the same.
• Undergoing chemotherapy post-surgery and at risk of developing oral mucositis.
• Willing to participate and provide informed consent.
• No known allergies to the Db platinum mucoadhesive patch components.

Exclusion Criteria

• Patients with severe (Grade 4) oral mucositis at baseline.
• History of severe allergic reactions to herbal or nanoparticle-based formulations.
• Presence of active oral infections (bacterial, viral, or fungal).
• Pregnant or lactating women or those with severe systemic illnesses.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Oral Mucositis Severity	The follow-up schedule includes assessments at Day 0 (baseline), Day 3 (early pain reduction and safety check), Day 7 (mucositis improvement and compliance check), Day 14 (final mucositis grading and microbial analysis), Day 21 (extended healing evaluation if needed), and Day 30 (long-term QoL assessment). These timepoints provide a comprehensive evaluation of the therapeutic efficacy, safety, and patient adherence to the Db platinum mucoadhesive patch
Measured using the World Health Organization (WHO) Oral Mucositis Grading Scale or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).	The follow-up schedule includes assessments at Day 0 (baseline), Day 3 (early pain reduction and safety check), Day 7 (mucositis improvement and compliance check), Day 14 (final mucositis grading and microbial analysis), Day 21 (extended healing evaluation if needed), and Day 30 (long-term QoL assessment). These timepoints provide a comprehensive evaluation of the therapeutic efficacy, safety, and patient adherence to the Db platinum mucoadhesive patch
Assessed by the reduction in ulcer size, severity of pain, and ability to eat/drink	The follow-up schedule includes assessments at Day 0 (baseline), Day 3 (early pain reduction and safety check), Day 7 (mucositis improvement and compliance check), Day 14 (final mucositis grading and microbial analysis), Day 21 (extended healing evaluation if needed), and Day 30 (long-term QoL assessment). These timepoints provide a comprehensive evaluation of the therapeutic efficacy, safety, and patient adherence to the Db platinum mucoadhesive patch

Secondary Outcome Measures

Name	Time	Method
Pain Reduction	Assessed using the Visual Analog Scale (VAS) (0 = no pain, 10 = worst pain).

Trial Locations

Locations (1)

SAVEETHA DENTAL COLLEGE & HOPSITALS; 🇮🇳 Chennai, TAMIL NADU, India

SAVEETHA DENTAL COLLEGE & HOPSITALS

🇮🇳Chennai, TAMIL NADU, India

Dr Nitya Krishnasamy

Principal investigator

09962623510

drknitya@gmail.com