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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363201
• Other study ID #: CAT2024/PED01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 28, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: April 2024
• Source: Catalysis SL
• Contact: Ingrid C. Arambu Elvir, Dr.
• Phone: 50498878486
• Email: ingridcarolinaa[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Advanced Solid Tumor
• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Germ Cell Tumor
• Hodgkin Disease
• Lymphoma, Hodgkin
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Nervous System Neoplasms
• Pediatric Cancer
• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
Honduras	Hospital Escuela, Tegucigalpa (Honduras)	Tegucigalpa	Francisco Morazan

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Honduras, 

References & Publications (25)

A teacupful of medicine? Nat Struct Mol Biol. 2008 Jun;15(6):537. doi: 10.1038/nsmb0608-537. — View Citation

Diaz-Rodriguez E, Hernandez-Garcia S, Sanz E, Pandiella A. Antitumoral effect of Ocoxin on acute myeloid leukemia. Oncotarget. 2016 Feb 2;7(5):6231-42. doi: 10.18632/oncotarget.6862. — View Citation

Fabozzi F, Trovato CM, Diamanti A, Mastronuzzi A, Zecca M, Tripodi SI, Masetti R, Leardini D, Muratore E, Barat V, Lezo A, De Lorenzo F, Caccialanza R, Pedrazzoli P. Management of Nutritional Needs in Pediatric Oncology: A Consensus Statement. Cancers (Basel). 2022 Jul 11;14(14):3378. doi: 10.3390/cancers14143378. — View Citation

Friedrich P, Lam CG, Itriago E, Perez R, Ribeiro RC, Arora RS. Magnitude of Treatment Abandonment in Childhood Cancer. PLoS One. 2015 Sep 30;10(9):e0135230. doi: 10.1371/journal.pone.0135230. eCollection 2015. — View Citation

Garcia-Perdomo HA, Gomez-Ospina JC, Reis LO. Immunonutrition hope? Oral nutritional supplement on cancer treatment. Int J Clin Pract. 2021 Nov;75(11):e14625. doi: 10.1111/ijcp.14625. Epub 2021 Jul 19. — View Citation

Gohar 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. — View Citation

Gomez EV, Perez YM, Sanchez HV, Forment GR, Soler EA, Bertot LC, Garcia AY, del Rosario Abreu Vazquez M, Fabian LG. Antioxidant and immunomodulatory effects of Viusid in patients with chronic hepatitis C. World J Gastroenterol. 2010 Jun 7;16(21):2638-47. doi: 10.3748/wjg.v16.i21.2638. — View Citation

Hernandez-Garcia S, Gonzalez V, Sanz E, Pandiella A. Effect of Oncoxin Oral Solution in HER2-Overexpressing Breast Cancer. Nutr Cancer. 2015;67(7):1159-69. doi: 10.1080/01635581.2015.1068819. Epub 2015 Aug 4. — View Citation

Hernandez-Unzueta I, Benedicto A, Olaso E, Sanz E, Viera C, Arteta B, Marquez J. Ocoxin oral solution(R) as a complement to irinotecan chemotherapy in the metastatic progression of colorectal cancer to the liver. Oncol Lett. 2017 Jun;13(6):4002-4012. doi: 10.3892/ol.2017.6016. Epub 2017 Apr 10. — View Citation

Joffe 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. — View Citation

Lam 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. — View Citation

Maruyama T, Murata S, Nakayama K, Sano N, Ogawa K, Nowatari T, Tamura T, Nozaki R, Fukunaga K, Ohkohchi N. (-)-Epigallocatechin-3-gallate suppresses liver metastasis of human colorectal cancer. Oncol Rep. 2014 Feb;31(2):625-33. doi: 10.3892/or.2013.2925. Epub 2013 Dec 13. — View Citation

Milligan SA, Burke P, Coleman DT, Bigelow RL, Steffan JJ, Carroll JL, Williams BJ, Cardelli JA. The green tea polyphenol EGCG potentiates the antiproliferative activity of c-Met and epidermal growth factor receptor inhibitors in non-small cell lung cancer cells. Clin Cancer Res. 2009 Aug 1;15(15):4885-94. doi: 10.1158/1078-0432.CCR-09-0109. Epub 2009 Jul 28. — View Citation

Orgel E, Genkinger JM, Aggarwal D, Sung L, Nieder M, Ladas EJ. Association of body mass index and survival in pediatric leukemia: a meta-analysis. Am J Clin Nutr. 2016 Mar;103(3):808-17. doi: 10.3945/ajcn.115.124586. Epub 2016 Feb 10. — View Citation

Palagyi A, Balane C, Shanthosh J, Jun M, Bhoo-Pathy N, Gadsden T, Canfell K, Jan S. Treatment abandonment in children with cancer: Does a sex difference exist? A systematic review and meta-analysis of evidence from low- and middle-income countries. Int J Cancer. 2021 Feb 15;148(4):895-904. doi: 10.1002/ijc.33279. Epub 2020 Sep 22. — View Citation

Ringwald-Smith K, Hill R, Evanoff L, Martin J, Sacks N. When Reality and Research Collide: Guidelines Are Essential for Optimal Nutrition Care in Pediatric Oncology. J Pediatr Hematol Oncol. 2022 Jan 1;44(1):e144-e151. doi: 10.1097/MPH.0000000000002200. — View Citation

Roomi MW, Roomi N, Ivanov V, Kalinovsky T, Niedzwiecki A, Rath M. Inhibition of pulmonary metastasis of melanoma b16fo cells in C57BL/6 mice by a nutrient mixture consisting of ascorbic Acid, lysine, proline, arginine, and green tea extract. Exp Lung Res. 2006 Nov-Dec;32(10):517-30. doi: 10.1080/01902140601098552. — View Citation

Siddiqui IA, Asim M, Hafeez BB, Adhami VM, Tarapore RS, Mukhtar H. Green tea polyphenol EGCG blunts androgen receptor function in prostate cancer. FASEB J. 2011 Apr;25(4):1198-207. doi: 10.1096/fj.10-167924. Epub 2010 Dec 21. — View Citation

Steliarova-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. Erratum In: Lancet Oncol. 2017 Jun;18(6):e301. — View Citation

Tachibana H, Koga K, Fujimura Y, Yamada K. A receptor for green tea polyphenol EGCG. Nat Struct Mol Biol. 2004 Apr;11(4):380-1. doi: 10.1038/nsmb743. Epub 2004 Mar 14. — View Citation

Varni 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. — View Citation

Varni 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. — View Citation

Varni 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. — View Citation

Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x. — View Citation

Yang C, Du W, Yang D. Inhibition of green tea polyphenol EGCG((-)-epigallocatechin-3-gallate) on the proliferation of gastric cancer cells by suppressing canonical wnt/beta-catenin signalling pathway. Int J Food Sci Nutr. 2016 Nov;67(7):818-27. doi: 10.1080/09637486.2016.1198892. Epub 2016 Jun 24. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

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