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Completed

NCT Number: NCT03717298

Evaluation of Ocoxin-Viusid® in Advanced Pancreatic Adenocarcinoma

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.

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Key information

Conditions

Adenocarcinoma of the Pancreas Advanced Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

"Hermanos Ameijeiras" Surgical Clinical Hospital

La Habana, 10300, Cuba

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Oct 24, 2018
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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