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 Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Eligible participants will be:
- •Adult male and non pregnant and non lactating female patients (age group
- •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).
- •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
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: At Baseline 1,2,3,4,5,6,7 weeks or two weeks after completion of RT whichever is later.
Secondary Outcomes
- 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.)
Investigators
Dr Arpit Gupta
Postgraduate Institute of Medical education and Research