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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04995354

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis	Drug: EGF loaded Hydrogel Drug: Hydrogel	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Self Healing Gel as a Vehicle for Recombinant Human Epidermal Growth Factor in Treatment of Oral Mucositis Following Cancer Therapy

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EGF loaded Hydrogel (Gp I) 30 patients will receive EGF loaded Hydrogel (Intervention 1) to be applied three times a day for 1weeks.	Drug: EGF loaded Hydrogel 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 Other Names: Epidermal Growth Factor-loaded Hydrogel
Active Comparator: Hydrogel alone ( Gp II) 30 patients will receive Hydrogel alone (Intervention 2) to be applied three times a day for 2 weeks.	Drug: Hydrogel Non-medicated self-healing hydrogel to be applied three times a day for 1 week Other Names: Self-healing Hydrogel
No Intervention: Control (Gp III) 30 patients will receive the standard of care treatment (Control) which includes benzydamine mouthwash, increased hydration, topical analgesics and antifungals.

Arm

Intervention/Treatment

Experimental: EGF loaded Hydrogel (Gp I)

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

Drug: EGF loaded Hydrogel

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

Other Names:

Epidermal Growth Factor-loaded Hydrogel

Active Comparator: Hydrogel alone ( Gp II)

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

Drug: Hydrogel

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

Other Names:

Self-healing Hydrogel

No Intervention: Control (Gp III)

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

Outcome Measures

Primary Outcome Measures

The European Organization for Research and Treatment of Cancer Quality of Life questionnaire [Baseline]
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
WHO grade of mucositis [Baseline]
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
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire [After 7 days of treatment]
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
WHO grade of mucositis [After 7 days of treatment]
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
The European Organization for Research and Treatment of Cancer Quality of Life questionnaire [After 14 days of treatment.]
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
WHO grade of mucositis [After 14 days of treatment.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Basma AA Zakaria, PhD, Lecturer at the Faculty of Dentistry - Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Basma Elsaadany, Lecturer of oral medicine and periodontology, Cairo University

ClinicalTrials.gov Identifier:

NCT04995354

Other Study ID Numbers:

MucoCU

First Posted:

Aug 6, 2021

Last Update Posted:

Aug 6, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mucositis

Stomatitis

Mitogens

Study Results

No Results Posted as of Aug 6, 2021