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

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

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 Overview

• Status: Unknown
• Conditions: Quality of Life; Infection; Drug Toxicity
• Intervention / Treatment: Dietary supplement: AferBio

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlos E Paiva, MD, PhD; Phone Number: 6786 +551733216600; Email: caredupai@gmail.com
• Study Contact Backup: Name: Bianca SR Paiva, RN, PhD; Phone Number: +551733216600; Email: bsrpaiva@gmail.com

Study Locations

• Brazil
  • SP
    • Barretos, SP, Brazil, 14784400
      • Recruiting
      • Barretos Cancer Hospital
      • Contact: Carlos Paiva, PhD; Phone Number: 1733216600
      • Contact: Bianca Paiva, PhD; Phone Number: 1733216600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AferBio; Daily oral AferBio (20 g/day, in sachets)	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).
Placebo Comparator: Placebo; Daily oral placebo (20 g/day, in sachets)	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Barretos Cancer Hospital

Publications and helpful links

General Publications

• D'Almeida Preto D, Baston MT, Geraige CC, Augusto SB, de Oliveira MA, Mamere AE, Pinto GDJ, Dias JM, De Marchi PRM, Paiva BSR, Paiva CE. Impact of AferBio(R) on quality of life and chemotherapy toxicity in advanced lung cancer patients (AFERBIO study): protocol study for a phase II randomized controlled trial. BMC Cancer. 2019 Apr 25;19(1):382. doi: 10.1186/s12885-019-5599-z.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 28, 2018
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: BarretosCH-20174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No