Mucositis post chemotherapy [unsealed radioactive].
Conditions
Interventions
Epidermal growth factor administration in viscous solution (10µg/ml), using the topical route of administration (oral) three times a day, for a 20-day term.
Epidermal Growth Factor
Administration, Oral
Hebervis
Sponsors
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Cuban patients (both sexes and any skin color), fulfilling the above-mentioned diagnosis criterion. 2. Patients 1-18 years of age. 3. Voluntariness of the patient and parents or guardians, through the signing of the informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergy or antecedent of intolerance to biotechnology derivative products or some formulation components. 2. Serious systemic disorders that make treatment administration and the evaluation difficult.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe conditions of lesions will be determined daily, by the qualitative evaluation of patients through the clinical examination of the mucosa area, considering the phases in accordance with WHO: Grade 0: None. (There is no clinical symptomatology). Grade 1: Erythema. (There is only flare of the mucosa area). Grade 2: Erythema, ulcers in the mucosa area. The patient can eat solid foods. Slight pain. Grade 3: Erythema, edema, ulcers in the mucosa area. The patient can consume only liquid diet. Acute pain. Grade 4: Enteral or parenteral support. Acute pain. The following are the response criteria to be considered: -Favorable response: Lesions heal in a 10-day or less term. -Partial response: Lesions heal in a 10-15-day term; otherwise, to go from a superior to an inferior grade, during the same time. (Grades according to WHO scale). -Unfavorable response: No heal after 15 days. Grades 1, 2 - 3, 4 even administering the product. (Grades according to WHO scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| -General condition of the patient will be evaluated daily, through the OAG scale: This is a scale that results in mucosa changes from the initial to the final phase of the disease OAG gives quantitative and qualitative standards in eight items (values 1-3); the sum gives a rough estimate about the evolution of the patient (general condition). The higher the value of the scale, the worsen the evolution of the patient and vice versa -The following are the local adverse reactions will be considered: pruritus, burning, pain, exanthema, vesicle, bump, eschar, bleeding and the sudden or marked appearance of edema. | — |
Countries
Cuba
Contacts
Public ContactTania Gonzalez Lopez
Center for Genetic Engineering and Biotechnology.(CIGB), in Havana.
Outcome results
None listed