Evaluation of Ocoxin®-Viusid® in Breast Cancer

NCT03576521 | Completed Phase 2 DMC

• 1 other identifier: OOS-CANCER-11
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to determine the efficacy of the nutritional supplement Ocoxin-Viusid oral solution (OV) in the reduction of acute toxicity of Chemotherapy (CT) treatment with patients with breast carcinoma. A randomized, double-blind phase II clinical trial was designed, with a sample of 120 patients distributed in 2 arms: 60 patients will receive the CT treatment plus the OV, 60 will receive CT plus OV placebo. The OV / placebo will be administered before, during and 3 weeks after the conclusion of the CT. A better tolerance to the treatment is expected with the addition of the nutritional supplement.

Conditions

Breast Cancer; Breast Carcinoma; Adriamycin Toxicity; Cyclosporine Toxicity

Keywords

breast cancer; chemotherapy toxicity; Oxidative Stress; Nutritional supplement; Ocoxin Viusid

Outcome Measures

Primary Outcomes (3)

• The Ocoxin-Viusid effect in the treatment with chemotherapy

  The effect of the treatment will be evaluated from the number of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.

  4 months

• Compliance with the planned chemotherapy schedule

  Dichotomous variable that will be evaluated through the answer yes or no. In cases of negative response, the cause of non-compliance will be collected. It will be collected in the evaluation corresponding to each cycle of chemotherapy and in the final evaluation.

  4 months

• The Ocoxin-Viusid effect in the treatment with chemotherapy

  The effect of the treatment will be evaluated from the percentage of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.

  4 months

Secondary Outcomes (6)

• Evaluation of Quality of Life

  4 months

• Evaluation of Quality of Life

  4 months

• Evaluation of Quality of Life

  4 months

• Evaluation of nutritional status

  4 months

• Evaluation of nutritional status

  4 months

Study Arms (2)

Ocoxin-Viusid®

EXPERIMENTAL

The CT with Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + OV nutritional supplement.

Combination Product: CT + Ocoxin-Viusid

Placebo

PLACEBO COMPARATOR

The QT Adriamycin scheme 60 mg per m2 of Body Surface (SC) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + a placebo of the OV nutritional supplement.

Combination Product: CT + Placebo

Interventions

CT + Ocoxin-Viusid COMBINATION_PRODUCT

The included patients received the Ocoxin-Viusid nutritional supplement at a rate of 75 ml daily (25 ml in 3 doses every 8 hours) administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment\* and up to three weeks after the end of the treatment. \*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center.

Ocoxin-Viusid®

CT + Placebo COMBINATION_PRODUCT

The included patients received the OV placebo in oral solution at a rate of 75 ml daily (25 ml in 3 doses every 8 hours), administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment\* and up to three weeks after the end of the treatment. \*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age ≥18 years of female sex.
• General health status according to the Karnofsky Index ≥ 70.
• Laboratory parameters within the normal limits defined to receive this chemotherapy including normal Echocardiogram:
• to. Hematopoietic: Hemoglobin ≥ 9 g / L, Total Leukocytes ≥ 3 x 109 cells / L, Neutrophils ≥ 1.5 x 109 cells / L, Platelets ≥ 100 x 109 / L.
• b. Hepatic: Liver function within 2.5 times upper normal limit and without liver disease demonstrated by TGP, OGT and alkaline phosphatase.
• c. Renal function: creatinine ≤ 132 μmol / l.
• Patients who express written voluntariness to enter the study with their signature of the informed consent document.
• Patients of childbearing age with negative pregnancy test or who have effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation.

You may not qualify if:

• Patients who have received prior chemotherapy.
• Patients who are receiving another research product.
• Patients with known hypersensitivity to any ingredient of the investigational product.
• Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic diseases and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health or life at risk during your participation in the trial.
• Pregnancy, lactation or puerperium.
• Patients with cerebral metastases and / or leptomeningeal carcinosis.
• Patients with a second concomitant tumor.
• Patients carrying the human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

National Institute of Oncology and Radiobiology (INOR)

La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ocoxin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A double blind. The masking will be maintained until the analysis of the data. However, access to the code will be allowed if serious adverse events arise related to the research product.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase II randomized, controlled, double blind clinical trial.

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 3, 2018
• Study Start: May 13, 2015
• Primary Completion: January 1, 2018
• Study Completion: February 19, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU (1)