NCT04995354

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DRUG	Hydrogel	Non-medicated self-healing hydrogel to be applied three times a day for 1 week

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2021-08-06
• Last updated: 2021-08-06