Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial to Assess the Impact of AferBio® on Quality of Life and Toxicity to Chemotherapy in Patients With NSCLC Beginning Second-line Palliative Mono-chemotherapy

Conditions
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Quality of Life, Infection, Drug Toxicity

Intervention / Treatment
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* Dietary Supplement: AferBio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above or equal to 18 years, and below 75 years; Diagnosis of metastatic or recurrent NSCLC, beginning second-line palliative mono-chemotherapy treatment; Functional capacity (ECOG-PS) grade 0 - 2; Adequate hematological, kidney and liver function, as follows: Total neutrophil count ≥ 1500/μL Platelet count ≥ 100.000/μL Hemoglobin ≥ 9 g/dL Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) Patients with confirmed Gilbert's syndrome and serum bilirubin ≤ 3 × ULN Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min based on the Cockcroft-Gault equation: (140 - age) × (weight in Kkg) × (0.85) 72 × (serum creatinine in mg/dL) Absence of any emotional, family-related, sociological, or geographic condition that can potentially hamper adherence to the study protocol and the follow-up schedule; Capacity and willingness to adhere to the study visits and tests, and to adhere to the protocol, according to the researcher's evaluation. Exclusion Criteria: Tube feeding, gastrostomy- or jejunostomy; Uncontrollable vomiting; Sexually active women of reproductive age, except for those who underwent surgical sterilization (e. g., tubal ligation); Intestinal obstruction or sub-obstruction; Known allergy to any of the components of the investigational product; Malabsorption syndrome or other condition that could interfere with enteric absorption; History of inflammation of the small or large intestine, previous or currently active (such as Crohn's disease or ulcerative colitis); Chronic diarrhea of any cause; Diagnosis of any chronic disease that, in the researcher's opinion, will interfere with the participation in the study; Known diagnosis of HIV -infection; Diagnosis of any chronic disease that changes the immune system and significantly increases the risk of infection; The need to use G-CSF already in the first chemotherapy cycle; Severe neuropsychiatric disease that prevents the patient from completing the study questionnaires, determined at the researcher's discretion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AferBio<br>Daily oral AferBio (20 g/day, in sachets) | Dietary Supplement: AferBio<br>* 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).<br>|
| Placebo Comparator: Placebo<br>Daily oral placebo (20 g/day, in sachets) | Dietary Supplement: AferBio<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related QOL scores over time. | To compare health-related QOL scores among the arms of the study over time. | Over time (during 90 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | To compare the incidence of any given toxicity ≥ grade 3 (jointly and individually) | 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; | 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; | 3 months | 
| Dose intensity | To compare the dose intensity (in mg/m2/week) among the arms of the study | 3 months | 
| Dose-reduction rates | To compare dose-reduction rates (≥ 20 %) and calculate dose reduction-free survival among the arms of the study; | 3 months | 
| Hospitalizations | To compare the number of hospitalizations among the arms of the study; | 3 months | 
| Infections | To compare the number of infections (any grade) among the arms of the study. | 3 months | 
| Use of anti-microbials | To compare the number of patients that used anti-microbials among the arms of the study. | 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. | 3 months | 
| Incidence of febrile neutropenia | To compare the incidence of febrile neutropenia among the arms of the study. | 3 months | 
| ECOG-PS worsening-free survival | To compare worsening-free survival of the ECOG-PS (> 1 point) among the arms of the study | Along the study (3 months) | 
| Nutritional status | To compare nutritional status among the arms of the study | Along the study (3 months) | 
| Antineoplastic response rates | To compare antineoplastic response rates among the arms of the study | 3 months | 
| Progression-free survival | To compare progression-free survival among the arms of the study | 3 months | 
| Adherence to AferBio® | To assess adherence to treatment with AferBio® | 3 months |