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CTRI Number  CTRI/2024/08/072901 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry
Process of Care Changes
Other (Specify) [management of disease/condition]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two mouthwashes to treat mouth mucositis and improve quality of life after radiation therapy in head and neck cancer patients. 
Scientific Title of Study   Comparing the effectiveness of novel VG111(Sepil) with Benzydamine on radiation induced oral mucositis and QoL in head and neck cancer subjects: A Randomized Controlled Trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arpit Gupta 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical education and Research 
Address  Oral Health Sciences Center, PGIMER, Sector 12 Chandigarh India

Chandigarh
CHANDIGARH
160012
India 
Phone  8826674284  
Fax  -  
Email  arpitg.in@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arpit Gupta 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical education and Research 
Address  Oral Health Sciences Center, PGIMER, Sector 12 Chandigarh India

Chandigarh
CHANDIGARH
160012
India 
Phone  8826674284  
Fax  -  
Email  arpitg.in@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arpit Gupta 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical education and Research 
Address  Oral Health Sciences Center, PGIMER, Sector 12 Chandigarh India

Chandigarh
CHANDIGARH
160012
India 
Phone  8826674284  
Fax  -  
Email  arpitg.in@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR), New Delhi 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V.Ramalingaswami Bhawan, P.O Box N0.4911 Ansari Nagar, New Delhi 110029 India India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Arpit Gupta  Postgraduate Institute of Medical education and Research  Room no. 107,Preventive clinic ground floor, Oral health sciences center PGIMER sector 12
Chandigarh
CHANDIGARH 
8826674284

arpitg.in@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Extramural) PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Benzydamine Hydrochloride  Rinse with 15 ml of Benzydamine (0.15%) mouthwash for 1-2 minutes, four to eight times daily and is to be started one week before RT till 7 weeks or two weeks after completion of RT whichever is later 
Intervention  VG111 Sepil mouthwash  Rinse with VG111(SEPIL) mouthwash -10ml of aqueous extract of the sepil solution for 1-2 minutes, two to four times daily and is to be started one week before RT till 7 weeks or two weeks after completion of RT whichever is later.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Eligible participants will be: 1. Adult male and non pregnant and non lactating female patients (age group 18 - 70 years old) with oral cavity and oropharyngeal cancer that has been diagnosed histologically, and planned to receive three dimensional Conformal RT (3D CRT) and three dimensional conformal (concurrent chemoradiotherapy- CCRT) (1 week before the commencement of the therapy).2. rated with Karnofsky performance status score greater than or equal to 70% (to assess the ability of the patients to follow instructions) without a prior history of radiation to the head and neck. 3.Minimum white blood counts of 3000/L and platelet counts 100000/L. 
 
ExclusionCriteria 
Details  Abnormal liver or kidney function.
Severe periodontal disease, herpes simplex virus, and oral ulcer.
Will receive intensity modulated radiotherapy (IMRT) or neoadjuvant chemotherapy for head and neck cancer.
ALT/AST values greater than 200 IU/L on the screening test, serum creatinine levels greater than 2.0 mg/dL on the screening test.
A history of cytotoxic chemotherapy or radiation therapy within three weeks of the study, or use of systemic or topical oral corticosteroids within 30 days of the study, or participation in another clinical investigation of any other topical oral formulations within 30 days of the study.
Individuals taking drugs like steroids, amifostine, G(M)-CSF, sucralfate slurry, or cryotherapy will be excluded.
Patients on anticoagulant medications, those with hypercalcemia, current tobacco users, people with any sort of mental or physical abnormality, and people who use any other mouthwash will be excluded.
Patients who are physically disabled or near death, which may impair their usage of mouthwash.
Patients who have a history of NSAID or benzydamine hydrochloride hypersensitivity will also be excluded.


 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of incidence, progression, and severity of Radiation induced oral mucositis. Primary: Assessment of the incidence, progression and severity of RIOM through WHO Oral toxicity scale and Oral Mucositis Assessment Scale at weekly interval.  At Baseline 1,2,3,4,5,6,7 weeks or two weeks after completion of RT whichever is later.  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of changes in salivary inflammatory mediators at baseline, 3rd and 7th week of the interventions.
Comparison of effect of VG111 mouthwash on adverse events of RadioTherapy by using Common Terminology Criteria for Adverse Events (CTCAE) v5.0, dysphagia, oral pain by using Numeric Rating Scale, significant weight loss at weekly intervals respectively.
The Quality of Life will be assessed by using UW-QOL v4.1 at baseline, 3rd and 7th week or last visit.

 
At Baseline 3rd and 7th week of the interventions.

Adverse events at weekly intervals. 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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 3 
Date of First Enrollment (India)   23/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Radiation induced oral mucositis (RIOM) is a common health problem among the Head and neck cancer subjects undergoing Radiotherapy. Paucity of good quality trials involving efficacious agents evaluating the self applied, less toxic and more efficacious formulations needing least resources and less technique sensitivity over professionally applied  treatment modalities needs concerns. Novelity: VG111 (Sepil), is a novel natural formulation containing extract of Sesamum indicum L., Azadirachta indica, Honey bee wax and others which is developed at PGIMER, Chandigarh  as an ideal wound healing product that acts by lowering IL-6 and TNF-α levels. ObjectivesTo compare the effectiveness of VG111 mouthwash over benzydamine hydrochloride mouthwash in reducing incidence, progression and severity of RIOM among RT subjects of oral cavity and oropharyngeal cancer and changing the salivary inflammatory mediators and reduction of adverse effects due to RT like dysphagia, oral pain, significant weight loss and QoL. This study is randomized, triple blinded, two arm, parallel clinical trial comparing the effectiveness the novel VG111(Sepil) mouthwash -10ml of aqueous extract of solution for two to four times daily and Benzydamine Hydrochloride(0.15%) four to eight times daily and to be started one week before radiotherapy till 7 weeks or 2 weeks after completion in 124 patients that will be conducted in India. The primary outcome will be the assessment of incidence, progression and severity of Radiation Induced Oral mucositis through WHO Oral toxicity scale  and Oral mucositis assessment scale(OMAS). The secondary outcome will be the change in salivary inflammatory mediators at baseline third and seventh week of interventions. The indigenously prepared solutions can prove to be an effective RIOM preventive regimen that can be implemented sustainably in developing nations due to self applied and other properties. 

 

 

    












 
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