Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

Gastrointestinal Neoplasms Clinical Trial

Official title:

Evaluation of the Effect of the Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Metastatic Colorectal Adenocarcinoma. Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559543
• Other study ID #: OOS-CANCER-9
• Status: Completed
• Phase: Phase 2
• Start date: October 25, 2018
• Est. completion date: January 15, 2024

Study information

• Verified date: February 2024
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.

Description:

- To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients. - To evaluate the influence of Ocoxin®-Viusid® on tolerance to onco-specific therapy. - Identify the changes that occur in the nutritional status of patients receiving the supplement. - To evaluate the toxicity of Ocoxin®-Viusid® in combination with chemotherapy in patients with metastatic colorectal adenocarcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 15, 2024
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
• Patients that meet the diagnostic criteria.
• Patients with general health according to Karnofsky =70%.
• Life expectancy greater than or equal to 3 months.
• Patients eligible to receive FOLFOX-IV chemotherapy.
• Patients who have signed the informed consent.
• Patients who have laboratory values in parameters that do not contraindicate the

administration of chemotherapy:

• Hemoglobin = 90 g / l
• Total Leukocyte Count = 3.0 x 109 / L
• Absolute Neutrophil Count =1.5 x 109 / L
• Platelet Count =100 x 109 / L
• Total bilirubin values = 1.5 times the upper limit of the normal range established in the institution.
• TGO and TGP values =2.5 times the upper limit of the normal interval established in the institution.
• Creatinine values within the normal limits of the institution.

Exclusion Criteria:

• Pregnant or lactating patients.
• Patients with known hypersensitivity to (5 Fluoracil, Folinic Acid or Oxaliplatin).
• Patients who are receiving another product under investigation.
• Patients with decompensated intercurrent diseases, including: hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial.
• Patients with brain metastases.
• Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up. It is planned to include a total of 40 patients in the study, taking into account 10% of losses.

Related Conditions & MeSH terms

• Adenocarcinoma
• Colonic Diseases
• Colorectal Neoplasm
• Colorectal Neoplasms
• Digestive System Disease
• Digestive System Diseases
• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Intestinal Disease
• Intestinal Diseases
• Intestinal Neoplasms
• Neoplasms
• Rectal Diseases

Intervention

Dietary Supplement:
• Ocoxin-Viusid
An oral solution of Oncoxin® (30 ml vials) will be used at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and lunch. It will be prescribed for a period of 2 weeks before starting the QT up to 3 weeks after finishing the treatment. The treatment with Oncoxin®-Viusid® will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the oncospecific treatment. The treatment will be administered continuously for approximately 29 weeks from the patient's inclusion in the study.

Locations

Country	Name	City	State
Cuba	National Institute of Oncology and Radiobiology (INOR)	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

References & Publications (14)

Bardia A, Tleyjeh IM, Cerhan JR, Sood AK, Limburg PJ, Erwin PJ, Montori VM. Efficacy of antioxidant supplementation in reducing primary cancer incidence and mortality: systematic review and meta-analysis. Mayo Clin Proc. 2008 Jan;83(1):23-34. doi: 10.4065/83.1.23. — View Citation

Block KI, Koch AC, Mead MN, Tothy PK, Newman RA, Gyllenhaal C. Impact of antioxidant supplementation on chemotherapeutic toxicity: a systematic review of the evidence from randomized controlled trials. Int J Cancer. 2008 Sep 15;123(6):1227-39. doi: 10.1002/ijc.23754. — 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

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

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

Prasad KN, Hernandez C, Edwards-Prasad J, Nelson J, Borus T, Robinson WA. Modification of the effect of tamoxifen, cis-platin, DTIC, and interferon-alpha 2b on human melanoma cells in culture by a mixture of vitamins. Nutr Cancer. 1994;22(3):233-45. doi: 10.1080/01635589409514349. — View Citation

Rodrigues MJ, Bouyon A, Alexandre J. [Role of antioxidant complements and supplements in oncology in addition to an equilibrate regimen: a systematic review]. Bull Cancer. 2009 Jun;96(6):677-84. doi: 10.1684/bdc.2009.0886. French. — 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

Vilar Gomez E, Sanchez Rodriguez Y, Torres Gonzalez A, Calzadilla Bertot L, Arus Soler E, Martinez Perez Y, Yasells Garcia A, Abreu Vazquez Mdel R. Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial. BMJ Open. 2011 Jan 1;1(2):e000140. doi: 10.1136/bmjopen-2011-000140. — 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 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: EORTC QLQ-C30 (general quality of life in cancer patients: Physical, Role, Emotional, Cognitive, Social, Overall quality of life, Fatigue, Nausea and vomiting, Pain valorated from 1 to 4)	8 months
Primary	Quality of life	Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: QLQ-CR29 specific questionnaire of quality of life in colon cancer (Urinary frequency, Blood and mucus in stool, Stool frequency and Body image, Urinary incontinence, Dysuria, Abdominal pain, Buttock pain , Bloating, Dry mouth, Hair loss, Taste, Anxiety, Weight, Flatulence, Faecal incontinence, Sore skin, Embarrassment, Stoma care problems, Sexual interest, Impotence, Dyspareunia valorated from 1 to 4).	8 months
Primary	Tolerance of Chemotherapy	Treatment with chemotherapy (CT) FOLFOX-IV will be considered	8 months
Primary	Nutritional status	Variations in the patient's nutritional status and weight at the end of treatment will be considered	8 months