Efficacy of EGF-loaded Self Healing Gel in Treatment of Oral Mucositis

NCT04995354 | Unknown Phase 2

• 1 other identifier: MucoCU
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Mucositis can dramatically affect the patient's quality of life .Epidermal growth factor (EGF) is a dominant factor in early keratinocyte differentiation, proliferation and migration. However, a major obstacle in most studies is that there isn't prolonged contact between the applied treatment and the oral mucosa to achieve the optimum therapeutic effect. Thus, a new vehicle for EGF is needed to achieve sufficient prolonged contact with oral mucosa. The present project aims at employing EGF as therapeutic agent for mucositis dealing with the challenges of delivery of such macromolecule to the oral mucosa by using self-healing gels to maximize the drug effect.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (6)

• The European Organization for Research and Treatment of Cancer Quality of Life questionnaire

  Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf

  Baseline

• WHO grade of mucositis

  Grade 1 Soreness, with or without erythema Grade 2 Erythema, ulcers; still able to swallow solid foods Grade 3 Ulcers with extensive erythema; unable to swallow solid foods Grade 4 Ulcers with extensive erythema; alimentation not possible

  Baseline

• The European Organization for Research and Treatment of Cancer Quality of Life questionnaire

  Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf

  After 7 days of treatment

• WHO grade of mucositis

  Grade 1 Soreness, with or without erythema Grade 2 Erythema, ulcers; still able to swallow solid foods Grade 3 Ulcers with extensive erythema; unable to swallow solid foods Grade 4 Ulcers with extensive erythema; alimentation not possible

  After 7 days of treatment

• The European Organization for Research and Treatment of Cancer Quality of Life questionnaire

  Questionnaire developed to assess the quality of life of cancer patients. The questionnaire used will be for that for head and neck patients (EORTC QLQ - H\&N43) https://www.eortc.org/app/uploads/sites/2/2018/08/Specimen-HN43-English.pdf

  After 14 days of treatment.

• WHO grade of mucositis

  Grade 1 Soreness, with or without erythema Grade 2 Erythema, ulcers; still able to swallow solid foods Grade 3 Ulcers with extensive erythema; unable to swallow solid foods Grade 4 Ulcers with extensive erythema; alimentation not possible

  After 14 days of treatment.

Study Arms (3)

EGF loaded Hydrogel (Gp I)

EXPERIMENTAL

30 patients will receive EGF loaded Hydrogel (Intervention 1) to be applied three times a day for 1weeks.

Drug: EGF loaded Hydrogel

Hydrogel alone ( Gp II)

ACTIVE COMPARATOR

30 patients will receive Hydrogel alone (Intervention 2) to be applied three times a day for 2 weeks.

Drug: Hydrogel

Control (Gp III)

NO INTERVENTION

30 patients will receive the standard of care treatment (Control) which includes benzydamine mouthwash, increased hydration, topical analgesics and antifungals.

Interventions

EGF loaded Hydrogel DRUG

Patients will receive 25 Ug/day of EGF. This is the estimated daily dose that will be obtained when the patient applies the gel thrice daily. Patients will receive the treatment for one week

Also known as: Epidermal Growth Factor-loaded Hydrogel

EGF loaded Hydrogel (Gp I)

Hydrogel DRUG

Non-medicated self-healing hydrogel to be applied three times a day for 1 week

Also known as: Self-healing Hydrogel

Hydrogel alone ( Gp II)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients are those over 18 years of age with WHO grade 3 or 4 oral mucositis receiving radio- or chemotherapy as treatment for head and neck cancer.

You may not qualify if:

• Patients with hematologic malignancies or those with known allergic reactions to the drug.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Stomatitis

Interventions

Hydrogels

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Gels; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Basma AA Zakaria, PhD

  Lecturer at the Faculty of Dentistry - Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha A Azab, PhD

CONTACT

01001381954; noha.adel@dentistry.cu.edu.eg

Mai Zakaria, PhD

CONTACT

noha.adel@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Containers supplied for groups I and II will be identical and will be supplied by a third party pharmacist not a member of this study to ensure participant and patient blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of oral medicine and periodontology

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: June 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share