| 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 |
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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. |
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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.
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Method of Generating Random Sequence
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Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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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. |
|
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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" |
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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 |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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. Objectives: To 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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