Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis

NCT04303312 | Unknown Phase 3

• 1 other identifier: OMED 2_2_1
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

Oral mucositis consequences can range from pain, decreased oral intake, impaired speech and swallowing to adverse events as severe as septicemia, increased hospitalization, and G-tube feeding A wide variety of agents have been tested to prevent OM or reduce its severity.This trial will assess the usefulness of solcoseryl and pumpkin seed oil versus Benzydamine Hydrochloride mouth wash in management of oral mucositis in patients receiving radiotherapy and/or chemotherapy.

Conditions

Mucositis Oral

Keywords

Oral Mucositis; Pumpkin seed oil; Solcoseryl

Outcome Measures

Primary Outcomes (1)

• Clinical improvement

  World Health Organization (WHO)scale.It is graded from 0 to 4. If the patient has no signs and symptoms, it is graded as 0. If the patient has painless ulcers, edema, or mild soreness, it is graded as 1. If there is painful erythema, edema, or ulcers but able to eat, it is graded as 2. If there is painful erythema, edema, or ulcers but unable eat, it is graded as 3. If there a requirement for parenteral or enteral support, it is graded as 4

  20 days

Secondary Outcomes (1)

• Quality of life

  20 days

Study Arms (2)

Benzydamine Hydrochloride

ACTIVE COMPARATOR

Control Group:Benzydamine Hydrochloride spray by mouth three times daily for 20 days. Follow up: The patients will be recalled at one week interval for 20 days.

Combination Product: Solcoseryl and pumpkin seed oil

90%solcoseryl and 10% pumpkin seed oil

EXPERIMENTAL

Intervention group: 90% solcoseryl and 10% pumpkin seed oil spray by mouth three times daily for 20 days

Other: Benzydamine Hydrochloride

Interventions

Benzydamine Hydrochloride OTHER

Patients will rinse by mouth three times daily for 20 days

90%solcoseryl and 10% pumpkin seed oil

Solcoseryl and pumpkin seed oil COMBINATION_PRODUCT

Patients will receive by mouth three times daily for 20 days

Benzydamine Hydrochloride

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having clinical signs of chemotherapy-induced or radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III and IV)
• Patients over the age of 18 years
• Patients having no history of allergy, allergic rhinitis and asthma

You may not qualify if:

• Patients allergic to the used treatment
• Patient receiving systemic steroids
• Patients who don't approve to participating in the clinical trial.

Sponsors & Collaborators

• Ghada zaki: lead

MeSH Terms

Conditions

Stomatitis

Interventions

Benzydamine; Actihaemyl

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tissue Extracts; Complex Mixtures

Central Study Contacts

Ghada Zaki, Msc

CONTACT

01111122658; ghada.zaki@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Treatment will be placed in identical spray containers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer at el ahram canadian university

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 11, 2020
• Study Start: December 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: March 1, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-08