Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Arm A: Photobiomodulation Therapy (PBM) Alone: Daily photobiomodulation using a visible light LED device (wavelength 400 700 nm, fluence 145 J/cm , power 120 mW/cm ) for 15 minutes, adm
Sponsors
ACTREC, Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: -Age 18 to 70 years. -Karnofsky Performance Status (KPS)-70. -Histologically or cytologically confirmed, non-metastatic head and neck cancer involving the oral cavity or oropharynx. -Patients receiving radical or adjuvant radiotherapy without concurrent chemotherapy. -Adequate visual access for examination of the oral cavity. -Willing and able to provide written informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: -History of allergy to Tulsi, Turmeric, or any excipients of the study product. -History of allergy to phototherapy. -Prior radiotherapy or neoadjuvant chemotherapy or planned concurrent chemotherapy. -Presence of oral mucositis or other oral lesions at baseline. -Active oral infections or untreated dental disease that could interfere with the study. -Significant, uncontrolled medical conditions (e.g., uncontrolled diabetes, hypertension, severe cardiovascular or pulmonary disease). -Any systemic disorder or condition affecting the oral cavity that may interfere with study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of PBM alone and PBM combined with PAF (Turcumin drops) versus standard of care in reducing the incidence and severity of Grade 3 and above oral mucositis (CTCAE v5).Timepoint: Assessed weekly during radiotherapy, at end of treatment (week 6 7), and at 3 months post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| -Evaluate the safety and tolerability of PBM + PAF compared to PBM alone. -Compare the time to onset of oral mucositis between PBM, PBM + PAF groups and standard of care. -Assess quality of life using validated tools (UW-QOL) in both groups. -Evaluate changes in salivary and blood biomarkers/cytokines of inflammation and tissue repair between the groups. Timepoint: -Time to onset of oral mucositis will be recorded weekly during radiotherapy until the first occurrence of Grade 2 or higher mucositis. -Quality of life (UW-QOL questionnaire) will be evaluated at baseline, at the end of radiotherapy (week 6 7), and at 3 months post-treatment. -Safety and tolerability (adverse events and serious adverse events) will be monitored weekly during radiotherapy, at end of treatment, and at 3 months post-treatment. -Salivary and blood biomarker levels will be measured at baseline, mid-treatment, end of treatment, and 3 months after completion of radiotherapy. | — |
Countries
India
Contacts
Public ContactAnuj Kumar S
ACTREC,Tata Memorial Centre
Outcome results
None listed