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CTRI Number  CTRI/2025/07/090333 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Radiation Therapy
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on Light Therapy With or Without Turmeric Drops to Reduce Mouth Sores During Cancer Treatment 
Scientific Title of Study   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) 
Trial Acronym  PROMPT 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol Version 1.2, dated 28.05.25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuj Kumar S  
Designation  Assistant Professor  
Affiliation  ACTREC,Tata Memorial Centre  
Address  Dept of Radiation Oncology, ACTREC, Tata Memorial Centre, Sector 22, Kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  9946416480  
Fax    
Email  anujkumar.tvm@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Anuj Kumar S  
Designation  Assistant Professor  
Affiliation  ACTREC,Tata Memorial Centre  
Address  Dept of Radiation Oncology, ACTREC, Tata Memorial Centre, Sector 22, Kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  9946416480  
Fax    
Email  anujkumar.tvm@gmail.com   
 
Details of Contact Person
Public Query  
Name  Anuj Kumar S  
Designation  Assistant Professor  
Affiliation  ACTREC,Tata Memorial Centre  
Address  Dept of Radiation Oncology, ACTREC, Tata Memorial Centre, Sector 22, Kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  9946416480  
Fax    
Email  anujkumar.tvm@gmail.com   
 
Source of Monetary or Material Support  
ACTREC, Tata Memorial Centre , Sector 22,Kharghar, Navi Mumbai, Maharashtra 410210, India  
 
Primary Sponsor  
Name  ACTREC, Tata Memorial Centre 
Address  Sector 22,Kharghar, Navi Mumbai, Maharashtra 410210 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anuj Kumar  ACTREC  Room No: 23, Dept of Radiation Oncology, Proton Therapy Centre, ACTREC, Sector 22, Kharghar, Navi Mumbai-410210 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9946416480

anujkumar.tvm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-3, Tata Memorial Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm A: Photobiomodulation Therapy (PBM) Alone  Daily photobiomodulation using a visible light LED device (wavelength 400–700 nm, fluence 145 J/cm², power 120 mW/cm²) for 15 minutes, administered 30–120 minutes before radiotherapy sessions, 5 days per week for 6–7 weeks. 
Intervention  Arm B: PBM + Curcuma longa Oral Drops  Curcuma longa (turmeric oil) oral drops (10–15 drops) applied directly into the oral cavity, followed by daily PBM as described in Arm A. Treatment given prior to radiotherapy sessions for 6–7 weeks.  
Comparator Agent  Standard Supportive Care  Institutional standard oral care including saline rinses, analgesics, and antimicrobial mouthwashes as needed, administered during radiotherapy for 6–7 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  -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.
 
 
ExclusionCriteria 
Details  -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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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).  Assessed weekly during radiotherapy, at end of treatment (week 6–7), and at 3 months post-treatment 
 
Secondary Outcome  
Outcome  TimePoints 
-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.
 		 -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. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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