Hebervis administration in patients suffering from buccal mucositis caused by chemotherapy [unsealed

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000063
• Date of registration: 27/12/2010
• Primary sponsor: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
• Public title: Hebervis administration in patients suffering from buccal mucositis caused by chemotherapy [unsealed
• Scientific title: Hebervis administration in patients suffering from buccal mucositis caused by chemotherapy [unsealed radioactive].
• Date of first enrolment: 16/03/2008
• Target sample size: 30
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000063-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Tania Gonzalez Lopez
• Affiliation: Center for Genetic Engineering and Biotechnology.(CIGB), in Havana.

• Name: Tania Gonzalez Lopez
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Key inclusion & exclusion 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: 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.

Age minimum: 1 year
Age maximum: 18 years
Gender: Both

Health Condition(s) or Problem(s) studied

Mucositis post chemotherapy [unsealed radioactive].

Intervention(s)

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.

Primary Outcome(s)

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 Outcome(s)

-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.

Secondary ID(s)

IG/FCG/MC/0207

Source(s) of Monetary Support

Heber Biotec S.A. Ministry of Public Health, CUBA

Secondary Sponsor(s)

Not applicable