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

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

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.

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.

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

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

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

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

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

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

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

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

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

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

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.