To hear about similar clinical trials, please enter your email below
Trial Title:
Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
NCT ID:
NCT06363201
Condition:
Advanced Cancer
Advanced Solid Tumor
Lymphoma, Hodgkin
Central Nervous System Tumor
Sarcoma
Germ Cell Tumor
Pediatric Cancer
Conditions: Official terms:
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Hodgkin Disease
Conditions: Keywords:
Epigallocatechin gallate
Paediatric
Advanced Solid Tumor
Quality of Life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Ocoxin Oral solution
Description:
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.
Arm group label:
Ocoxin Oral Solution
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.
Criteria for 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.
Gender:
All
Minimum age:
7 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Escuela, Tegucigalpa (Honduras)
Address:
City:
Tegucigalpa
Zip:
504
Country:
Honduras
Contact:
Last name:
Ingrid C. Arambú Elvir, Dr.
Phone:
50498878486
Email:
ingridcarolinaa@yahoo.com
Investigator:
Last name:
Ingrid C. Arambú Elvir, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Alejandra Elonor Zapata, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Clarissa L. Aguilar Molina, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Darío Vinicio Cáceres, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Gerardo Ismael Castro, Dr.
Email:
Sub-Investigator
Start date:
April 28, 2024
Completion date:
December 15, 2025
Lead sponsor:
Agency:
Catalysis SL
Agency class:
Industry
Source:
Catalysis SL
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06363201
