Sarcoma Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 15, 2025 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Honduras | Hospital Escuela, Tegucigalpa (Honduras) | Tegucigalpa | Francisco Morazan |
Lead Sponsor | Collaborator |
---|---|
Catalysis SL |
Honduras,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Degree of toxicity related to oncospecific treatment | 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 | |
Secondary | Nutritional Status | 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 | |
Secondary | Presence of Adverse Events (AE) | 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 | |
Secondary | Metabolic Status | 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 | |
Secondary | Physical Status | 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 | |
Secondary | Response to oncospecific treatment | 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 |
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