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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGF loaded Hydrogel (Gp I) | Experimental | 30 patients will receive EGF loaded Hydrogel (Intervention 1) to be applied three times a day for 1weeks. |
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| Hydrogel alone ( Gp II) | Active Comparator | 30 patients will receive Hydrogel alone (Intervention 2) to be applied three times a day for 2 weeks. |
|
| Control (Gp III) | No Intervention | 30 patients will receive the standard of care treatment (Control) which includes benzydamine mouthwash, increased hydration, topical analgesics and antifungals. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGF loaded Hydrogel | Drug | 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noha A Azab, PhD | Contact | 01001381954 | noha.adel@dentistry.cu.edu.eg | |
| Mai Zakaria, PhD | Contact | noha.adel@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Basma AA Zakaria, PhD | Lecturer at the Faculty of Dentistry - Cairo University | Principal Investigator |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D020100 | Hydrogels |
| ID | Term |
|---|---|
| D005782 | Gels |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 |
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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.
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| Hydrogel | Drug | Non-medicated self-healing hydrogel to be applied three times a day for 1 week |
|
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| 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. |
| Pharmaceutical Preparations |