Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Intervention1: Mucoplat: Desmostachya bipinnata-derived platinum nanocomplex is integrated into a mucoadhesive patch to provide targeted therapy for chemotherapy-induced oral mucositis. This novel for
Sponsors
Department of Health Research
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Oral Mucositis Severity Measured using the World Health Organization (WHO) Oral Mucositis Grading Scale or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Assessed by the reduction in ulcer size, severity of pain, and ability to eat/drinkTimepoint: 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
| Measure | Time frame |
|---|---|
| Pain Reduction Assessed using the Visual Analog Scale (VAS) (0 = no pain, 10 = worst pain). Healing Rate of Oral Ulcers Measured by lesion size reduction & complete resolution percentage. Patient-Reported Quality of Life Evaluated using Oral Mucositis Quality of Life (OMQoL) scale or other validated tools. Time to Mucositis Resolution Days taken for complete healing of oral lesions. Timepoint: Time Points for Outcome Assessment Baseline (Day 0): Before starting the intervention (Initial assessment). Week 1: Early response to treatment. Week 2: Mid-treatment evaluation. Week 4: Primary outcome assessment to determine efficacy. Week 6: Follow-up to assess sustained effects. Week 8: Final evaluation for long-term healing & relapse prevention.. | — |
Countries
India
Contacts
Public ContactNitya Krishnasamy
Saveetha Dental College and Hospitals
Outcome results
None listed