Comparative Efficacy of Rebamipide Gargle And Benzydamine HCL Gargle in Prevention and Management of Chemo- and Radio-therapy-induced Oral Mucositis

Phase 3

• Conditions: Oral Mucositis
• Interventions: Drug: Ribamipide gargle \benzdymine HCL gargel

• Registration Number: NCT04685395
• Lead Sponsor: Cairo University

Brief Summary

evaluate preventive and therapeutic effects of Rebamipide gargle on reducing incidence of oral mucositis in comparison with benzydamine HCL mouthwash.

Detailed Description

Oral mucositis is a common and potentially dangerous complication of anticancer treatment. Inflammation and ulcerations of the oral mucosa make swallowing and, thereby, eating and drinking, difficult or even impossible, leading to anorexia and weight loss(Araújo et al., 2018) .There is a serious risk of infections and even sepsis, particularly in immune-ompromised patients. OM is associated with severe pain, affects the quality of life, and often requires reduction or suspension of chemotherapy and/or radiotherapy, thereby decreasing the relative dose intensity, which may worsen prognosis (Shumsky et al., 2019).

Benzydamine hydrochloride is a widely used drug in dentistry , a non-steroidal anti-inflammatory drug, has shown topical anti-inflammatory, analgesic, anaesthetic and antimicrobial effects and is used to attenuate inflammatory conditions like radiation -induced oral mucositis or chemotherapy-induced oral mucositis (Nithin, et al.,2018). In addition to this, Benzydamine HCL is available on the Egyptian market and its price is economical .Rebamipide is a drug used for the treatment of gastritis and gastric ulcer. The mechanisms involved in the anti-ulcer and cytoprotective effects of rebamipide have been reported to include an effect on prostaglandin E2 synthesis via COX-2 expression (Udagawaet al ., 2003), up-regulation of growth factors and their receptors such as EGF and HGF ,induction of mucus secretion ,anti-free radical effects and inhibition of the production of inflammatory cytokines such as IL-1, IL-8, and TNF-α (Yasuda et al., 2011).

Different treatment options and drugs have been tested in OM, only some of which exhibited clinical relevance such as oral cryotherapy, keratinocyte growth factor and amino acids enriched diets. Therefore, there is a clear requirement for new approaches to the prevention and effective treatment of OM (Mallick, Benson, \& Rath, 2016)

In 2019 a meta-analysis performed by Akagi and his colleagues (Akagi et al., 2019) showed that gargling treatment with Rebamipide is superior to placebo for the development of mucositis and stomatitis due to chemo-radio-therapy, especially for severe cases of Grade 3 or higher. However, in order to confirm these trials, further well-designed analyses are needed, and evaluation of adverse events in observational studies are also required.

Study Timeline

• Study Start: 2019-12-26
• Status Verified: 2020-12
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-24
• Last Update Submitted: 2020-12-24
• Study First Posted: 2020-12-28
• Last Update Posted: 2020-12-28
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Male and female patients with head and neck cancer and who will be prescribed radiotherapy at least 60 Gy (Roopashri et al., 2011).

• Patients who will sign an informed consent,
• Patients older than 18 years of age,
• Patients having normal renal and liver functions

Exclusion Criteria

• . Use of dentures, or having any source of infection in the mouth.

• Allergy to rebamipide or benzydamine hydrochloride(Nithin et al., 2018) .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Benzydamine hydrochloride	Ribamipide gargle \benzdymine HCL gargel	group I ( benzdymine HCL ); subject will be instructed to use Benzydamine hydrochloride gargle 6 times daily and not to eat or drink for the subsequent 10 min from first day of radiation therapy (4-6 week) until 2 weeks after the end of treatment(end of radiation ). dose :5 ml every time dosage form ; mouth wash
Rebamipide	Ribamipide gargle \benzdymine HCL gargel	group II ( rebamipide) :subject will be instructed to use Rebamipide gargle 6 times daily and not to eat or drink for the subsequent 10 min from first day of radiation therapy (4-6 week) until 2 weeks after the end of treatment(end of radiation ). dosage form ; mouth wash

Primary Outcome Measures

Name	Time	Method
Incidence of oral mucositis	6-8 week will evaluate patient weekly from start of radiation	The following parameters will be recorded at baseline , every week from start of radiation therapy and 2 weeks after end of RT . The patient will be visited once prior to radiation then weekly throughout the period of the study:1-WHO Mucositis scale (Organization, 1979),Oral Mucositis Assessment Scale (OMAS)(Sonis, 2004)

Secondary Outcome Measures

Name	Time	Method
The pain score	8 week	The pain score (Cella et al., 2003) :will recorded using a 10-point scale, the Numerical Rating Scale (NRS), wherein 0=no pain and 10=worst possible pain; . These objective assessments will be obtained weekly following initiation of radiotherapy (4-6 week ) and until 2 weeks after end of RT .

Trial Locations

Locations (1)

Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine; 🇪🇬 Cairo, Egypt