NCT06363201

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, open-label, single-centre, exploratory study in paediatric patients with advanced stage solid tumours receiving oncospecific therapy. Ocoxin®: The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Catalysis S.L. of Spain. It comes in the form of 30 ml single-dose vials. Forty paediatric patients will be included, distributed as follows: Hodgkin's lymphoma (10), Central Nervous System tumours (10), Sarcoma of any type (10) or Germinal Tumours (10). Patients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy. Prior to the start of treatment and before each cycle of QT, a haemogram and haemochemistry including albumin, total proteins, transaminases (TGO, TGP) will be performed. Physical examinations will be performed, and the patient's vital signs and body weight will be evaluated. Prior to the start of treatment, in month three and four weeks after the end of oncospecific therapy, a CT scan will be performed (depending on the type of tumour, the system for evaluating the efficacy of the oncospecific treatment will be adapted). Quality of life will be assessed using the paediatric quality of life questionnaire (PedsQLTm, version 4.0. Spanish). The questionnaire will be administered to the parent or guardian prior to the start of treatment, at month 3 and at the end of treatment with Ocoxin®. In the case of longer treatment regimens, intermediate quality of life measurements may be taken after the three months and before the end of treatment. The influence of Ocoxin® Oral solution on the prevention of admissions due to toxicity attributable to cancer-specific therapy and changes in the patient's nutritional status will also be assessed. Safety will be assessed by collecting adverse events (AEs), analytical parameters, physical examinations and vital signs. Effect and safety variables will be summarised using descriptive statistics and frequency counts.

Conditions

• Advanced Cancer
• Advanced Solid Tumor
• Lymphoma, Hodgkin
• Central Nervous System Tumor
• Sarcoma
• Germ Cell Tumor
• Pediatric Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ocoxin Oral solution	Patients will receive one vial of Ocoxin® orally daily, preferably at the same time each day. The duration of treatment will depend on the chemotherapy schedule the patient will receive. Treatment with Ocoxin® will be from the start of oncospecific therapy until two weeks after the end of therapy.

Timeline

• Start date: 2024-04-28
• Primary completion: 2024-12-15
• Completion: 2025-12-15
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: Honduras