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Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03717298
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Brief 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 Hospital. Phase II clinical trial, open, multicenter, nonrandomized.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Pancreas Pancreatic Cancer Advanced Cancer Digestive System Neoplasms Pancreatic Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Endocrine System Diseases Pancreatic Diseases Dietary Supplement: Ocoxin-Viusid® Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effect of Ocoxin-Viusid® Nutritional Supplement in the Life Quality in Patients Diagnosed With Advanced Pancreatic Adenocarcinoma. Phase II
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ocoxin-Viusid
It will be used at a rate of 60 ml daily (1 vial every 12 hours).
Dietary Supplement: Ocoxin-Viusid®

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.





Primary Outcome Measures :
  1. Quality of Life: EORTC QLQ-C30 [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Nutritional Status of the patient during Chemotherapy [ Time Frame: 12 months ]
    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)

  2. Adverse Events-AE during Chemotherapy Test [ Time Frame: 12 months ]

    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]


  3. Hematology test [ Time Frame: 12 months ]
    Levels of Hemoglobin, Platelets, Hemogram with differential in blood extractions.

  4. Blood Chemistry test [ Time Frame: 12 months ]
    Measure levels of GPT, GOT, Creatinine, Glycemia, Bilirrubin, Alkaline Phosphatase, LDH in blood.

  5. Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717298


Contacts
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Contact: Ivis Mendoza Hernández, MSc 7 204 8742 ivis@cencec.sld.cu
Contact: Yaima Muñoz Morejón, Dr. 7 204 8742 yaima@cencec.sld.cu

Locations
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Cuba
"Hermanos Ameijeiras" Surgical Clinical Hospital Recruiting
La Habana, Cuba, 10300
Contact: Mayté Lima Pérez, Dr.       mayte.lima@infomed.sld.cu   
Contact: Juan L. Soriano García, Dr.       soriano@infomed.sld.cu   
Principal Investigator: Mayte Lima Pérez, Dr.         
Principal Investigator: Jorge L. Soriano García, Dr.         
Sub-Investigator: Vilma Fleites Calvo, Dr.         
Sub-Investigator: Jorge Ortiz, Dr.         
Sub-Investigator: María E. Suardiaz, MSc         
Sub-Investigator: Yolanda Hernández García, NP         
Sub-Investigator: Amarilis Grau Cascudo, NP         
Sub-Investigator: Ivelisse Fleites, BSc         
Sub-Investigator: Carlos Domínguez, Dr.         
Sub-Investigator: Robin García Diéguez, BSc         
Sub-Investigator: Angela Gutiérrez, Dr.         
Sponsors and Collaborators
Catalysis SL

Publications:

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Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT03717298     History of Changes
Other Study ID Numbers: OOS-CANCER-6
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catalysis SL:
Nutritional supplement
Advanced Pancreatic adenocarcinoma
Ocoxin-Viusid
Oxidative stress
Antioxidant
Additional relevant MeSH terms:
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Digestive System Neoplasms
Digestive System Diseases
Adenocarcinoma
Pancreatic Neoplasms
Gastrointestinal Neoplasms
Endocrine Gland Neoplasms
Gastrointestinal Diseases
Pancreatic Diseases
Neoplasms
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site