Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours

Launched by CATALYSIS SL · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a product called Ocoxin® oral solution to see how it affects the quality of life for children and teenagers who have advanced solid tumors, which are types of cancer that can occur in various parts of the body. The trial aims to understand if taking this solution can help improve the overall well-being of young patients who are undergoing specific cancer treatments.

To participate in the study, children aged 7 to 18 years old must have a confirmed diagnosis of an advanced solid tumor and meet certain health requirements. A parent or guardian will need to give written consent, and older children (ages 12 to 18) will also provide their own written consent. Those who are pregnant, breastfeeding, or have allergies to any ingredients in Ocoxin® cannot take part in the trial. While the study is not yet recruiting participants, families interested in this option should know it could offer insights into new ways to support young patients dealing with challenging cancer diagnoses.

Gender

ALL

Eligibility criteria

• 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.