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Stomach NeoplasmPhase 2NCT03549494

Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction

A Phase 2 study testing Ocoxin-Viusid® in people with Stomach Neoplasm and Gastrointestinal 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

Our main objective is to evaluate the effect of Ocoxin-Viusid on the quality of life of patients with advanced stomach cancer and esophagogastric junction. The Ocoxin-Viusid nutritional supplement is expected to improve quality of life and tolerance to treatment with Chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ocoxin-Viusid®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteCuba
Study dates
25 Oct 2018to 15 Feb 2023
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 with cyto-histological diagnosis of stomach adenocarcinoma and gastric esophageal junction in stages III and IV, which are tributaries of the FOLFOX chemotherapy scheme.
  • Patients of any sex with age ≥ 18 years.
  • Patients with clinical status according to Karnofsky index ≥ 70%.
  • Patients with life expectancy ≥ 3 months.
  • Clinically fit patients to receive the FOLFOX chemotherapy scheme.
  • Patients who have signed informed consent for the investigation.
  • Patients with laboratory parameters within normal limits 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 ≤ 1.5 times the upper limit of the normal range established in the institution, TGO / TGP ≤2.5 times the upper limit of the normal range established in the institution, creatinine within the limits normal of the institution.
  • Patients of childbearing age with negative pregnancy test and use appropriate contraceptive methods such as intrauterine devices, barrier or tubal ligation methods, hormonal contraceptives. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.

Who cannot join

  • Patients with stomach cancer and gastric esophageal junction in stages III and IV, tributaries of surgical treatment and / or radiotherapy.
  • Patients who are being treated with another product under investigation.
  • Patients with known hypersensitivity to any component of the investigational product.
  • Patients with known hypersensitivity to any component of the Chemotherapy (FOLFOX).
  • Patients with acute allergic states or history of severe allergic reactions.
  • Patients with acute, chronic, or inflammatory decompensated infectious diseases.
Show all 9Show fewer
  • Patients with brain metastases.
  • Patients with psychiatric disorders that make it difficult to collect information, treatment or follow-up.
  • Patients in the period of breast-feeding or puerperium.

Trial locations and contacts

1 site in 1 country.

Cuba1 site

  • National Institute of Oncology and Radiobiology (INOR)

    Havana, La Habana, 10400

Other trials in Cuba

About this study

Official title: Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.

Our main objective is to evaluate the effect of Ocoxin-Viusid on the quality of life of patients with advanced stomach cancer and esophagogastric junction. The Ocoxin-Viusid nutritional supplement is expected to improve quality of life and tolerance to treatment with Chemotherapy.

Read the detailed description
  • To evaluate the effect of Ocoxin-Viusid on the quality of life of patients
  • To evaluate the toxicity of Ocoxin-Viusid in combination with chemotherapy (QT).
  • To assess the influence of Ocoxin-Viusid on tolerance to treatment with chemotherapy.
  • Identify the changes that occur in the nutritional status of patients receiving the supplement.
Being tested
Ocoxin-Viusid®
Medical subject headings
Stomach Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Esophageal Diseases

What participants receive

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

  • Ocoxin-Viusid®Dietary supplement

    Ocoxin-Viusid group (Experimental). Oral solution of Ocoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), administrado preferably administered after breakfast and dinner. The product will dilute in water, milk or juice. The treatment will have a period of 19 weeks, starting 2 weeks before the onco-specific treatment with FOLFOX chemotherapy and will end 3 weeks after the end of the sixth cycle of chemotherapy. QT FOLFOX will be prescribed intravenously every 14 days for 6 cycles as follows: Oxaliplatin (85 mg x m2) on day 1 Folinic acid (200 mg x m2) on day 1 and 2 5 Fluoracil (400 mg x m2, bolus) on day 1 and 2 5 Fluoracil (600 mg x m2, continuous infusion) on day 1 and 2

Study groups in NCT03549494
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

    Karnofsky index (Score of 0-100 points at intervals of 10).

    Measured: 5 months

  2. Quality of Life

    EORTC QLQ-C30 (score of every item and global score)

    Measured: 5 months

  3. Quality of Life

    EORTC QLQ-STO22 if gastric cancer (score of every item and global score)

    Measured: 5 months

  4. Quality of Life

    EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score)

    Measured: 5 months

Secondary outcomes (4)

  1. Nutritional Status

    Body mass Index calculated by Weight/(Height*Height), the weight expressed in Kg and, the height expressed in meters.

    Measured: 5 months

  2. Chemotherapy Tolerance

    Adverse Reactions (It will consider the compliance to the Chemotherapy treatment in terms of time and doses plan and, it will classify in "Yes, No").

    Measured: 5 months

  3. Adverse Events-AE

    AE will be measured as: - Type of AE (Description of the EA that is presented) - Causal Agent (QT, Oncoxin -Viusid, Other) - Seriousness of the AE (Serious, Not serious) - Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death, according to the Common Criteria of Adverse Event Terminology (CTCAE) version 4.0) - Duration of the AE (Difference between the start and end date of the event) - Causal relationship (Very likely/Definitive, Probable, Possible, Unlikely, Not related, Not assessable/Not classifiable according to the WHO classification) - Attitude towards treatment (No change, Modification of doses, Temporary interruption, Definitive interruption)

    Measured: 5 months

  4. Results of laboratory tests

    Hematological (hemoglobin, platelets, total leukocytes, CAN) and Blood chemistry (AST, ALT, total bilirubin, creatinine, glycemia, albumin, total proteins, alkaline phosphatase) .The values will be recorded according to the units established for each test, reporting as normal, abnormal, not clinically significant, abnormal clinically significant and not performed, according to the normality ranges of the institution)

    Measured: 5 months

Timeline

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

  1. First posted8 Jun 2018
  2. Study start25 Oct 2018
  3. Primary completion15 Jun 2022
  4. Study completion15 Feb 2023

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03549494
Sponsor's protocol ID
OOS-CANCER-8
Status last verified
Feb 2024
First submitted
25 May 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

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

    PubMed 21351269

  • Lamson DW, Brignall MS. Antioxidants in cancer therapy; their actions and interactions with oncologic therapies. Altern Med Rev. 1999 Oct;4(5):304-29.

    PubMed 10559547

  • Lamson DW, Brignall MS. Natural agents in the prevention of cancer, part two: preclinical data and chemoprevention for common cancers. Altern Med Rev. 2001 Apr;6(2):167-87.

    PubMed 11302780

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Lagergren P, Fayers P, Conroy T, Stein HJ, Sezer O, Hardwick R, Hammerlid E, Bottomley A, Van Cutsem E, Blazeby JM; European Organisation for Research Treatment of Cancer Gastrointestinal and Quality of Life Groups. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-OG25, to assess health-related quality of life in patients with cancer of the oesophagus, the oesophago-gastric junction and the stomach. Eur J Cancer. 2007 Sep;43(14):2066-73. doi: 10.1016/j.ejca.2007.07.005. Epub 2007 Aug 15.

    PubMed 17702567

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ocoxin-Viusid® in people with Stomach Neoplasm and Gastrointestinal 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 8 inclusion and 9 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: 5 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 NCT03549494, which also lists 11 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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