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

Quality of Life Clinical Trial

— AFERBIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469063
• Other study ID #: BarretosCH-20174
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2018
• Source: Barretos Cancer Hospital
• Contact: Carlos E Paiva, MD, PhD
• Phone: +551733216600
• Email: caredupai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: June 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Infection
• Quality of Life

Intervention

Dietary Supplement:
• AferBio
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).

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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