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

NCT06363201 | Not Yet Recruiting

• 1 other identifier: CAT2024/PED01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Epigallocatechin gallate; Paediatric; Advanced Solid Tumor; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Qualitative and quantitative data collection. To assess the effect of Ocoxin® on the quality of life of paediatric patients with advanced solid tumours by 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-month treatment and before the end of treatment.

  7 months

Secondary Outcomes (6)

• Degree of toxicity related to oncospecific treatment

  7 months

• Nutritional Status

  7 months

• Presence of Adverse Events (AE)

  7 months

• Metabolic Status

  7 months

• Physical Status

  7 months

Study Arms (1)

Ocoxin Oral Solution

EXPERIMENTAL

Patients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy.

Dietary Supplement: Ocoxin Oral solution

Interventions

Ocoxin Oral solution DIETARY_SUPPLEMENT

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.

Ocoxin Oral Solution

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

Hospital Escuela, Tegucigalpa (Honduras)

Tegucigalpa, Francisco Morazán Department, 504, Honduras

Location

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MeSH Terms

Conditions

Hodgkin Disease; Central Nervous System Neoplasms; Sarcoma; Neoplasms, Germ Cell and Embryonal; Neoplasms

Interventions

Ocoxin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neoplasms, Connective and Soft Tissue

Central Study Contacts

Ingrid C. Arambu Elvir, Dr.

CONTACT

50498878486; ingridcarolinaa@yahoo.com

Clarissa L. Aguilar Molina, Dr.

CONTACT

50499631144; claguilar01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: April 28, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

HO (1)