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Colorectal NeoplasmPhase 2NCT03559543

Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

A Phase 2 study testing Ocoxin-Viusid in people with Colorectal Neoplasm and Intestinal Neoplasms, run by Catalysis SL at 1 site in Cuba.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ocoxin-Viusid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCuba
Study dates
25 Oct 2018to 15 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Cuba1 site

  • National Institute of Oncology and Radiobiology (INOR)

    Havana, 10400

Other trials in Cuba

About this study

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

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.

Read the detailed 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.
Being tested
Ocoxin-Viusid
Keywords
Nutritional supplement, Metastatic colorectal Cancer, Oxidative Stress, Ocoxin Viusid, Antioxidant
Medical subject headings
Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Rectal Diseases, Colonic Diseases, Intestinal Diseases, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ocoxin-ViusidDietary supplement

    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.

Study groups in NCT03559543
Study groupRoleWhat they receive
Ocoxin-Viusid®ExperimentalNot described
Receives: Dietary Supplement: Ocoxin-Viusid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 8 months

  2. 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).

    Measured: 8 months

  3. Tolerance of Chemotherapy

    Treatment with chemotherapy (CT) FOLFOX-IV will be considered

    Measured: 8 months

  4. Nutritional status

    Variations in the patient's nutritional status and weight at the end of treatment will be considered

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start25 Oct 2018
  3. Primary completion30 Jun 2022
  4. Study completion15 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03559543
Sponsor's protocol ID
OOS-CANCER-9
Status last verified
Feb 2024
First submitted
6 Jun 2018
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 20518086

  • 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.

    PubMed 22021873

  • 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.

    PubMed 17169857

  • 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.

    PubMed 28599406

  • 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.

    PubMed 24337301

  • 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.

    PubMed 27338284

  • 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.

    PubMed 19638461

  • 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.

    PubMed 21177307

  • 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.

    PubMed 26756220

  • 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.

    PubMed 26241555

  • 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.

    PubMed 18173999

  • 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.

    PubMed 19493854

  • 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.

    PubMed 7877893

  • 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.

    PubMed 18623084

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ocoxin-Viusid in people with Colorectal Neoplasm and Intestinal Neoplasms, run by Catalysis SL at 1 site in Cuba.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03559543, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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