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

Cairo University (CU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Oral Mucositis

Treatments: Drug: EGF loaded Hydrogel; Drug: Hydrogel

Study type: Interventional

Funder types: Other

Identifiers

NCT04995354

MucoCU

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

EGF loaded Hydrogel (Gp I)

Experimental group

Description:

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

Treatment:

Drug: EGF loaded Hydrogel

Hydrogel alone ( Gp II)

Active Comparator group

Description:

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

Treatment:

Drug: Hydrogel

Control (Gp III)

No Intervention group

Description:

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