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

Primary Purpose

Oral Mucositis

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Ribamipide gargle \benzdymine HCL gargel
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) .

Sites / Locations

  • Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Benzydamine hydrochloride

Rebamipide

Arm Description

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 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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

The pain score
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 .

Full Information

First Posted
December 22, 2020
Last Updated
December 24, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04685395
Brief Title
Comparative Efficacy of Rebamipide Gargle And Benzydamine HCL Gargle in Prevention and Management of Chemo- and Radio-therapy-induced Oral Mucositis
Official Title
Comparative Efficacy of Rebamipide Gargle And Benzydamine HCL Gargle in Prevention and Management of Chemo- and Radio-therapy-induced Oral Mucositis in Head and Neck Cancer Patients: (A Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 26, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel group, two arm, superiority randomized controlled clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benzydamine hydrochloride
Arm Type
Active Comparator
Arm Description
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
Arm Title
Rebamipide
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ribamipide gargle \benzdymine HCL gargel
Other Intervention Name(s)
Ribamipide gargle \tantum mouth wash
Intervention Description
ribamipide gargle 6 time daily 5ml dosage
Primary Outcome Measure Information:
Title
Incidence of oral mucositis
Description
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)
Time Frame
6-8 week will evaluate patient weekly from start of radiation
Secondary Outcome Measure Information:
Title
The pain score
Description
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 .
Time Frame
8 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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) .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
souheir Jafar, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data collection and storage will be the responsibility of the candidate. Patient's personal information will be available to the candidate only. While the clinical and analytical data will be available to the entire research team.

Learn more about this trial

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

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