Drug Toxicity, Infection, Quality of Life
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAferBio
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).
Sponsors
Barretos Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related QOL scores over time. | Over time (during 90 days) | To compare health-related QOL scores among the arms of the study over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 20% reduction in HRQOL | Along the study (3 months) | To compare worsening-free survival of 20 % of the health-related QOL scores among the arms of the study; |
| Treatment delays | 3 months | To compare the numbers of days of treatment delay due to toxicity, infections or worse performance status among the arms of the study; |
| Dose intensity | 3 months | To compare the dose intensity (in mg/m2/week) among the arms of the study |
| Dose-reduction rates | 3 months | To compare dose-reduction rates (≥ 20 %) and calculate dose reduction-free survival among the arms of the study; |
| Hospitalizations | 3 months | To compare the number of hospitalizations among the arms of the study; |
| Infections | 3 months | To compare the number of infections (any grade) among the arms of the study. |
| Use of anti-microbials | 3 months | To compare the number of patients that used anti-microbials among the arms of the study. |
| Toxicity | 3 months | To compare the incidence of any given toxicity ≥ grade 3 (jointly and individually) |
| Incidence of febrile neutropenia | 3 months | To compare the incidence of febrile neutropenia among the arms of the study. |
| ECOG-PS worsening-free survival | Along the study (3 months) | To compare worsening-free survival of the ECOG-PS (\> 1 point) among the arms of the study |
| Nutritional status | Along the study (3 months) | To compare nutritional status among the arms of the study |
| Antineoplastic response rates | 3 months | To compare antineoplastic response rates among the arms of the study |
| Progression-free survival | 3 months | To compare progression-free survival among the arms of the study |
| Adherence to AferBio® | 3 months | To assess adherence to treatment with AferBio® |
| Use of G-CSF | 3 months | To compare the number of chemotherapy cycles with addition of granulocyte colony-stimulating factor (G-CSF) among the arms of the study. |
Countries
Brazil
Contacts
Primary ContactCarlos E Paiva, MD, PhD
Backup ContactBianca SR Paiva, RN, PhD
Outcome results
None listed