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

Study Overview
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Brief Summary
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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.

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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: EGF loaded Hydrogel
* Drug: Hydrogel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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. |