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

April 11, 2024 updated by: Catalysis SL

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Honduras
    • Francisco Morazan
      • Tegucigalpa, Francisco Morazan, Honduras, 504
        • Hospital Escuela, Tegucigalpa (Honduras)
        • Contact:
        • Principal Investigator:
          • Ingrid C. Arambú Elvir, Dr.
        • Sub-Investigator:
          • Alejandra Elonor Zapata, Dr.
        • Sub-Investigator:
          • Clarissa L. Aguilar Molina, Dr.
        • Sub-Investigator:
          • Darío Vinicio Cáceres, Dr.
        • Sub-Investigator:
          • Gerardo Ismael Castro, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ocoxin Oral Solution
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 7 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of toxicity related to oncospecific treatment
Time Frame: 7 months
Qualitative and quantitative data collection. To evaluate the influence of Ocoxin® in the prevention of admissions due to toxicity to cancer-specific therapy (NCI-CTC scales). Admissions for toxicity. Information related to the need for admissions for mucositis (World Health Organization mucositis grade) or other causes shall be collected at each assessment during treatment and at the final assessment.
7 months
Nutritional Status
Time Frame: 7 months
Qualitative and quantitative data collection. Changes in nutritional status. This will be assessed through body mass index (BMI) behavior at baseline, intermediate assessments, and final assessments.
7 months
Presence of Adverse Events (AE)
Time Frame: 7 months

Qualitative and quantitative data collection. Product and non-product related adverse events described and classified as follows:

Occurrence of any AE: yes/no Type: described according to the CTC nomenclature version 5.0 Duration: To be assessed by the start and end dates of the adverse event Intensity: To be assessed by the categories mild, moderate, severe, serious life-threatening or disabling, or serious life-threatening.

Causality: assessed as highly probable/certain, probable, possible, possible, unlikely, unrelated, and not assessable/unclassifiable Severity: yes/no. In case of yes, it will be classified according to the categories of: causes death of the patient, threatens life, requires hospitalisation or prolongs an existing hospitalisation, causes disability, significant or persistent disability, causes a birth defect or congenital anomaly.

Outcome: To be assessed according to the categories of recovered, improved, persists or sequelae.
7 months
Metabolic Status
Time Frame: 7 months
Qualitative and quantitative data collection. The metabolic status of patients will be assessed by laboratory tests. The tests described in the evaluations will be performed according to the study schedule (haemogram, albumin, total proteins, TGP, TGO). They will be classified as normal, non-clinically significant abnormal and clinically significant abnormal. Clinically significant abnormal findings in laboratory parameters will be reported as AE.
7 months
Physical Status
Time Frame: 7 months
Qualitative data collection. The physical status of patients shall be assessed by physical examination. The patient will be examined prior to study initiation, at on-treatment assessments, and at the end-of-treatment assessment. Any positive findings of clinical relevance on physical examination will be considered as an adverse event and will be described and classified as defined in the protocol for this type of event.
7 months
Response to oncospecific treatment
Time Frame: 7 months
Qualitative data collection (the evaluation method used will also include RECIST criteria, iRECIST criteria, Cheeson criteria or other, in which case the method will be specified). Objective response to oncospecific treatment will be assessed by characterising the type of response after clinical evaluation of the patient at the end of the chemotherapy regimen. This will be classified as complete response, partial response, disease stabilisation or progression, following the response criteria established for each treatment protocol according to the underlying disease treated.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 28, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT2024/PED01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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