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Adenocarcinoma of the PancreasPhase 2NCT03717298

Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma

A Phase 2 study testing Ocoxin-Viusid® in people with Adenocarcinoma of the Pancreas and Pancreatic Cancer, 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 investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical… 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
30 participants
Where
1 siteCuba
Study dates
30 Oct 2018to 20 Jan 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 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 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 any of the active ingredients of the chemotherapy used
  • 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 30 patients in the study, taking into account 10% of losses.

Trial locations and contacts

1 site in 1 country.

Cuba1 site

  • "Hermanos Ameijeiras" Surgical Clinical Hospital

    La Habana, 10300

Other trials in Cuba

About this study

Official title: Evaluation of the Effect of Ocoxin-Viusid® Nutritional Supplement in the Life Quality in Patients Diagnosed With Advanced Pancreatic Adenocarcinoma. Phase II

The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.

Read the detailed description

To assess the effect of Ocoxin-Viusid® on the quality of life of patients with advanced pancreatic adenocarcinoma.

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 advanced pancreatic adenocarcinoma.

Being tested
Ocoxin-Viusid®
Keywords
Nutritional supplement, Advanced Pancreatic adenocarcinoma, Ocoxin-Viusid, Oxidative stress, Antioxidant
Medical subject headings
Pancreatic Neoplasms, Digestive System Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Endocrine System Diseases, Pancreatic Diseases

What participants receive

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

  • Ocoxin-Viusid®Dietary supplement

    An oral solution of Ocoxin-Viusid® (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.

    The treatment with Ocoxin-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 from the inclusion of the patient in the study, up to one year.

Study groups in NCT03717298
Study groupRoleWhat they receive
Ocoxin-ViusidExperimentalIt will be used at a rate of 60 ml daily (1 vial every 12 hours).
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: EORTC QLQ-C30

    Life quality measurement through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (ORTC QLQ-C30): an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. It's composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: 12 months

Secondary outcomes (5)

  1. Nutritional Status of the patient during Chemotherapy

    Variations in the patient's nutritional status will be considered, measured by body mass Index (a measure of body fat based on height and weight that applies to adult men and women)

    Measured: 12 months

  2. Adverse Events-AE during Chemotherapy Test

    A test with the following questions:

    Occurrence of an AE in the subject [Yes, No]; Description of the AE [Name of the event]; Duration of the AE [Difference between the start and end date of the event]; Intensity of the AE [According to CTCAE version 4 it will classify in Light, Moderate, Severe, Life-threatening consequences, Death related to AE]; Seriousness of the AE [serious or not serious], Attitude with respect to the treatment under study [No changes, dose modification, temporary or definitive interruption of the study treatment], Result of the AE [recovered, improved, persisted or sequelae], Causal relationship [According to WHO algorithm it will classify in very probable, probable, possible, improbable, unrelated, not evaluable]

    Measured: 12 months

  3. Hematology test

    Levels of Hemoglobin, Platelets, Hemogram with differential in blood extractions.

    Measured: 12 months

  4. Blood Chemistry test

    Measure levels of GPT, GOT, Creatinine, Glycemia, Bilirrubin, Alkaline Phosphatase, LDH in blood.

    Measured: 12 months

  5. Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test

    Test with the next parameters: if the administration of chemotherapy (CT) and Immunotherapy (IT) treatments will be considered at planned time, number of the cycle administered out of date, days elapsed since the previous cycle and, cause that caused the administration of the CT/IT outside the planned date. In the case of the dose, the medication in which it was modified will be taken into account, as well as the modified dose.

    Measured: 12 months

Timeline

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

  1. First posted24 Oct 2018
  2. Study start30 Oct 2018
  3. Primary completion1 Dec 2022
  4. Study completion20 Jan 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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03717298
Sponsor's protocol ID
OOS-CANCER-6
Status last verified
Mar 2023
First submitted
28 Sep 2018
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.

    PubMed 9196156

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PubMed 21561347

  • Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

    PubMed 24131140

  • Tobita K, Kijima H, Dowaki S, Kashiwagi H, Ohtani Y, Oida Y, Yamazaki H, Nakamura M, Ueyama Y, Tanaka M, Inokuchi S, Makuuchi H. Epidermal growth factor receptor expression in human pancreatic cancer: Significance for liver metastasis. Int J Mol Med. 2003 Mar;11(3):305-9.

    PubMed 12579331

  • Burris H 3rd, Rocha-Lima C. New therapeutic directions for advanced pancreatic cancer: targeting the epidermal growth factor and vascular endothelial growth factor pathways. Oncologist. 2008 Mar;13(3):289-98. doi: 10.1634/theoncologist.2007-0134.

    PubMed 18378539

  • Ueda S, Ogata S, Tsuda H, Kawarabayashi N, Kimura M, Sugiura Y, Tamai S, Matsubara O, Hatsuse K, Mochizuki H. The correlation between cytoplasmic overexpression of epidermal growth factor receptor and tumor aggressiveness: poor prognosis in patients with pancreatic ductal adenocarcinoma. Pancreas. 2004 Jul;29(1):e1-8. doi: 10.1097/00006676-200407000-00061.

    PubMed 15211117

  • Korc M, Meltzer P, Trent J. Enhanced expression of epidermal growth factor receptor correlates with alterations of chromosome 7 in human pancreatic cancer. Proc Natl Acad Sci U S A. 1986 Jul;83(14):5141-4. doi: 10.1073/pnas.83.14.5141.

    PubMed 3014534

  • Immervoll H, Hoem D, Kugarajh K, Steine SJ, Molven A. Molecular analysis of the EGFR-RAS-RAF pathway in pancreatic ductal adenocarcinomas: lack of mutations in the BRAF and EGFR genes. Virchows Arch. 2006 Jun;448(6):788-96. doi: 10.1007/s00428-006-0191-8. Epub 2006 Apr 6.

    PubMed 16598499

  • Lee J, Jang KT, Ki CS, Lim T, Park YS, Lim HY, Choi DW, Kang WK, Park K, Park JO. Impact of epidermal growth factor receptor (EGFR) kinase mutations, EGFR gene amplifications, and KRAS mutations on survival of pancreatic adenocarcinoma. Cancer. 2007 Apr 15;109(8):1561-9. doi: 10.1002/cncr.22559.

    PubMed 17354229

  • Russo A, Rizzo S, Bronte G, Silvestris N, Colucci G, Gebbia N, Bazan V, Fulfaro F. The long and winding road to useful predictive factors for anti-EGFR therapy in metastatic colorectal carcinoma: the KRAS/BRAF pathway. Oncology. 2009;77 Suppl 1:57-68. doi: 10.1159/000258497. Epub 2010 Feb 2.

    PubMed 20130433

  • da Cunha Santos G, Dhani N, Tu D, Chin K, Ludkovski O, Kamel-Reid S, Squire J, Parulekar W, Moore MJ, Tsao MS. Molecular predictors of outcome in a phase 3 study of gemcitabine and erlotinib therapy in patients with advanced pancreatic cancer: National Cancer Institute of Canada Clinical Trials Group Study PA.3. Cancer. 2010 Dec 15;116(24):5599-607. doi: 10.1002/cncr.25393. Epub 2010 Sep 7.

    PubMed 20824720

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ocoxin-Viusid® in people with Adenocarcinoma of the Pancreas and Pancreatic Cancer, 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 28 Mar 2023. 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: EORTC QLQ-C30 (time frame: 12 months). 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 NCT03717298, 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 28 Mar 2023.

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