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

NCT ID: NCT04685395

Last Updated: 2020-12-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-26
• Study Completion Date: 2021-09-15

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.

Conditions

Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Benzydamine hydrochloride

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

Group Type: ACTIVE_COMPARATOR

Ribamipide gargle \benzdymine HCL gargel

Intervention Type: DRUG

ribamipide gargle 6 time daily 5ml dosage

Rebamipide

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

Group Type: ACTIVE_COMPARATOR

Ribamipide gargle \benzdymine HCL gargel

Intervention Type: DRUG

ribamipide gargle 6 time daily 5ml dosage

Interventions

Ribamipide gargle \benzdymine HCL gargel

ribamipide gargle 6 time daily 5ml dosage

Intervention Type: DRUG

Other Intervention Names

Ribamipide gargle \tantum mouth wash

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Samah Belag

assisstant lecture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

souheir Jafar, professor

Role: STUDY_DIRECTOR

Cairo University

Locations

Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine

Cairo, , Egypt

Countries

Egypt

References

Elsaadany B, Anayb SM, Mashhour K, Yossif M, Zahran F. Rebamipide gargle and benzydamine gargle in prevention and management of chemo-radiotherapy and radiotherapy-induced oral mucositis in head and neck cancer patients (randomized clinical trial). BMC Oral Health. 2024 Jun 1;24(1):645. doi: 10.1186/s12903-024-04379-3.

Reference Type: DERIVED

PMID: 38824583 (View on PubMed)

Other Identifiers

OMED2-2-1

Identifier Type: -

Identifier Source: org_study_id