Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Adva… (NCT06363201) | Clinical Trial Compass
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Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
Honduras40 participantsStarted 2024-04-28
Plain-language summary
Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours.
Who can participate
Age range7 Years – 18 Years
SexALL
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Inclusion Criteria:
* Patient of either sex in the paediatric age group, between 7 and 18 years of age.
* Father, mother or legal guardian who consents in writing to the minor's participation in the study. Written consent of the minor for ages 12 to 18 years. Verbal consent of the minor for ages 7 to 11 years.
* Histologically confirmed diagnosis of solid tumour of any location, in advanced stage, with criteria to receive oncospecific therapy.
* Patients with haematological parameters within normal figures that allow them to receive oncospecific therapy, according to the management protocols for each of the diseases.
Exclusion Criteria:
* Pregnancy or breast-feeding (if less than 3 months have elapsed since delivery, abortion, or breast-feeding prior to the start of treatment).
* Hypersensitivity to any component of the product under study (Ocoxin®).
* Any disease or condition that could interfere with the interpretation of the results.