Pilot Study to Evaluate the Safety and Efficacy of Photobiomodulation Therapy With and Without Photo-Adjuvant Formulation Compared to Standard of Care for Reducing Oral Mucositis in Head and Neck Cancer Patients Receiving Radiation Therapy (PROMPT)
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- ACTREC, Tata Memorial Centre
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 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).
Overview
Brief Summary
This is a pilot study to evaluate the safety and effectiveness of photobiomodulation therapy using a light-based device, with and without the addition of a turmeric-based oral formulation, in reducing the severity of oral mucositis in patients with head and neck cancer undergoing radiation therapy. A total of 45 patients will be enrolled and randomized into three groups. One group will receive light therapy alone, the second group will receive light therapy along with turmeric drops, and the third group will receive standard supportive care. The main outcome will be to assess how many patients develop severe mouth sores during treatment. The study also aims to measure changes in quality of life and certain biological markers of inflammation. The goal is to generate preliminary evidence that can help improve the management of treatment-related side effects in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 18 to 70 years.
- •Karnofsky Performance Status (KPS)-
- •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
- •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.
Outcomes
Primary Outcomes
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).
Time Frame: Assessed weekly during radiotherapy, at end of treatment (week 6–7), and at 3 months post-treatment
Secondary Outcomes
- -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.)
Investigators
Anuj Kumar S
ACTREC,Tata Memorial Centre