Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: 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
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: At Baseline 1,2,3,4,5,6,7 weeks or two weeks after completion of RT whichever is later. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: At Baseline 3rd and 7th week of the interventions. Adverse events at weekly intervals. | — |
Countries
India
Contacts
Public ContactDr Arpit Gupta
Postgraduate Institute of Medical education and Research
Outcome results
None listed