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

NCT04685395 | Unknown Phase 3 DMC

• 1 other identifier: OMED2-2-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Incidence of oral mucositis

  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)

  6-8 week will evaluate patient weekly from start of radiation

Secondary Outcomes (1)

• The pain score

  8 week

Study Arms (2)

Benzydamine hydrochloride

ACTIVE COMPARATOR

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

Drug: Ribamipide gargle \benzdymine HCL gargel

Rebamipide

ACTIVE COMPARATOR

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

Drug: Ribamipide gargle \benzdymine HCL gargel

Interventions

Ribamipide gargle \benzdymine HCL gargel DRUG

ribamipide gargle 6 time daily 5ml dosage

Also known as: Ribamipide gargle \tantum mouth wash

Benzydamine hydrochloride; Rebamipide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 38824583 DERIVED

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• souheir Jafar, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecture

Model Details: Parallel group, two arm, superiority randomized controlled clinical trial

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: December 26, 2019
• Primary Completion: June 30, 2021
• Study Completion: September 15, 2021
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)