Breast Cancer Clinical Trial
Official title:
Efficacy of Ocoxin-Viusid in the Prevention of Acute Toxicity by Chemotherapy in Patients With Breast Cancer. Phase II Clinical Trial
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.
To obtain the sample size, the proportion of patients presenting adverse reactions that
require interrupting chemotherapy treatment will be taken into account. In the institution,
this figure is close to 15%. Since it is a dietary supplement, with extensive information on
the safety of the product, the design is used in a stage of Flemming (without early stop
rules). Assuming that the Ocoxin-Viusid product would clearly be declared ineffective
(maximal ineffectiveness) if the proportion of patients not presenting adverse reactions was
equal to less than 85% (p0), that is the maximum level of success below which the product
does not shows signs of efficacy (the study does not guarantee further research) and taking a
p1 value of 95%, where p1 is the minimum level of efficacy required from which the product
would be declared effective (the results guarantee to continue a study phase III). Assuming
an α error of 5% (probability of rejecting the null hypothesis when it is true) and β
(probability of rejecting the alternative hypothesis when it is true) of 20% (the power of
the test: 1 - β = 80%), It is determined to recruit a maximum number of 59 - 60 subjects.
Determine a = 54, where a is the number of responses equal and below which the product is
declared ineffective (H0 is accepted). And r = a + 1 is the cut-off point, that is, the
number of responses from which the efficacy level ensures to continue to a phase III study.
In this case we would expect to obtain a number of successes ≥ 55.
Patients will be randomized after surgery, in the chemotherapy consultation, and once they
meet the established inclusion criteria. In order to achieve the masking of the research
product, these have been labeled by a balanced randomized list obtained by computer, which
will be in the possession of the Biostatistician of the study of the Clinical Investigations
Section of INOR and the promoter. The product under study has been consecutively labeled from
1 to 120 (60 patients in each therapeutic arm).
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