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

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04995354
• Other study ID #: MucoCU
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: Noha A Azab, PhD
• Phone: 01001381954
• Email: noha.adel[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.