Clinical trial · Interventional
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
NCT06363201CI-TRIAL-00075977unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Hodgkin | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ocoxin Oral solution | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ocoxin Oral Solution
- description
- Patients will receive one vial of Ocoxin® daily from the start of oncospecific therapy until two weeks after the end of therapy.
- interventionNames
- Dietary Supplement: Ocoxin Oral solution
Primary outcomes (1)
- measure
- Quality of Life
- timeFrame
- 7 months
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (25)
- BACKGROUNDSteliarova-Foucher E, Colombet M, Ries LAG, Moreno F, Dolya A, Bray F, Hesseling P, Shin HY, Stiller CA; IICC-3 contributors. International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol. 2017 Jun;18(6):719-731. doi: 10.1016/S1470-2045(17)30186-9. Epub 2017 Apr 11. PMID 28410997
- BACKGROUNDLam CG, Howard SC, Bouffet E, Pritchard-Jones K. Science and health for all children with cancer. Science. 2019 Mar 15;363(6432):1182-1186. doi: 10.1126/science.aaw4892. PMID 30872518
- BACKGROUNDGohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16. PMID 21370414
- BACKGROUNDVarni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006. PMID 11468499
- BACKGROUNDVarni JW, Katz ER, Seid M, Quiggins DJ, Friedman-Bender A, Castro CM. The Pediatric Cancer Quality of Life Inventory (PCQL). I. Instrument development, descriptive statistics, and cross-informant variance. J Behav Med. 1998 Apr;21(2):179-204. doi: 10.1023/a:1018779908502. PMID 9591169
- BACKGROUNDVarni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428. PMID 11932914
- BACKGROUNDJoffe L, Ladas EJ. Nutrition during childhood cancer treatment: current understanding and a path for future research. Lancet Child Adolesc Health. 2020 Jun;4(6):465-475. doi: 10.1016/S2352-4642(19)30407-9. Epub 2020 Feb 13.