- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04685395
Comparative Efficacy of Rebamipide Gargle And Benzydamine HCL Gargle in Prevention and Management of Chemo- and Radio-therapy-induced Oral Mucositis
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Cairo, Egypt
- Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 |
ribamipide gargle 6 time daily 5ml dosage
Other Names:
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Active Comparator: 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 |
ribamipide gargle 6 time daily 5ml dosage
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of oral mucositis
Time Frame: 6-8 week will evaluate patient weekly from start of radiation
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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)
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6-8 week will evaluate patient weekly from start of radiation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pain score
Time Frame: 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 . |
8 week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: souheir Jafar, professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMED2-2-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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