Clinical trial NCT06363201: Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Cancer
Advanced Solid Tumor
Lymphoma, Hodgkin
Central Nervous System Tumor
Sarcoma
Germ Cell Tumor
Pediatric Cancer
Keywords: Epigallocatechin gallate
Paediatric
Advanced Solid Tumor
Quality of Life
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Quality of Life
timeFrame: 7 months
Secondary outcomes:
measure: Degree of toxicity related to oncospecific treatment
timeFrame: 7 months
measure: Nutritional Status
timeFrame: 7 months
measure: Presence of Adverse Events (AE)
timeFrame: 7 months
measure: Metabolic Status
timeFrame: 7 months
measure: Physical Status
timeFrame: 7 months
measure: Response to oncospecific treatment
timeFrame: 7 months
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Hospital Escuela, Tegucigalpa (Honduras)
state: Francisco Morazan
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: A teacupful of medicine? Nat Struct Mol Biol. 2008 Jun;15(6):537. doi: 10.1038/nsmb0608-537.
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.
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.
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.
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.
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.