The AFERBIO study will evaluates safety and potential benefit of AferBio® in patients with non-small cell lung cancer undergoing at least a second-line palliative monochemotherapy. AferBio® is a fermented supplement in powder form obtained through biotechnological processes developed in Brazil. In this double-blind placebo-controlled randomized clinical trial, participants starting a new palliative regimen will be allocated to AferBio® or placebo. The primary aim will be to compare health-related QOL scores among the arms of the study over time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
104
Patients will use the product (AferBio/Placebo) once a day for seven days, and then twice a day, continuously (for a total of three months of use).
Barretos Cancer Hospital
Barretos, São Paulo, Brazil
RECRUITINGHealth-related QOL scores over time.
To compare health-related QOL scores among the arms of the study over time.
Time frame: Over time (during 90 days)
Toxicity
To compare the incidence of any given toxicity ≥ grade 3 (jointly and individually)
Time frame: 3 months
20% reduction in HRQOL
To compare worsening-free survival of 20 % of the health-related QOL scores among the arms of the study;
Time frame: Along the study (3 months)
Treatment delays
To compare the numbers of days of treatment delay due to toxicity, infections or worse performance status among the arms of the study;
Time frame: 3 months
Dose intensity
To compare the dose intensity (in mg/m2/week) among the arms of the study
Time frame: 3 months
Dose-reduction rates
To compare dose-reduction rates (≥ 20 %) and calculate dose reduction-free survival among the arms of the study;
Time frame: 3 months
Hospitalizations
To compare the number of hospitalizations among the arms of the study;
Time frame: 3 months
Infections
To compare the number of infections (any grade) among the arms of the study.
Time frame: 3 months
Use of anti-microbials
To compare the number of patients that used anti-microbials among the arms of the study.
Time frame: 3 months
Use of G-CSF
To compare the number of chemotherapy cycles with addition of granulocyte colony-stimulating factor (G-CSF) among the arms of the study.
Time frame: 3 months
Incidence of febrile neutropenia
To compare the incidence of febrile neutropenia among the arms of the study.
Time frame: 3 months
ECOG-PS worsening-free survival
To compare worsening-free survival of the ECOG-PS (\> 1 point) among the arms of the study
Time frame: Along the study (3 months)
Nutritional status
To compare nutritional status among the arms of the study
Time frame: Along the study (3 months)
Antineoplastic response rates
To compare antineoplastic response rates among the arms of the study
Time frame: 3 months
Progression-free survival
To compare progression-free survival among the arms of the study
Time frame: 3 months
Adherence to AferBio®
To assess adherence to treatment with AferBio®
Time frame: 3 months
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