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

Primary Purpose

Quality of Life, Infection, Drug Toxicity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
AferBio
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barretos Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AferBio

Placebo

Arm Description

Daily oral AferBio (20 g/day, in sachets)

Daily oral placebo (20 g/day, in sachets)

Outcomes

Primary Outcome Measures

Health-related QOL scores over time.
To compare health-related QOL scores among the arms of the study over time.

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2018
Last Updated
June 13, 2018
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03469063
Brief Title
Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 28, 2018 (Anticipated)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Infection, Drug Toxicity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AferBio
Arm Type
Experimental
Arm Description
Daily oral AferBio (20 g/day, in sachets)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily oral placebo (20 g/day, in sachets)
Intervention Type
Dietary Supplement
Intervention Name(s)
AferBio
Intervention Description
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).
Primary Outcome Measure Information:
Title
Health-related QOL scores over time.
Description
To compare health-related QOL scores among the arms of the study over time.
Time Frame
Over time (during 90 days)
Secondary Outcome Measure Information:
Title
Toxicity
Description
To compare the incidence of any given toxicity ≥ grade 3 (jointly and individually)
Time Frame
3 months
Title
20% reduction in HRQOL
Description
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)
Title
Treatment delays
Description
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
Title
Dose intensity
Description
To compare the dose intensity (in mg/m2/week) among the arms of the study
Time Frame
3 months
Title
Dose-reduction rates
Description
To compare dose-reduction rates (≥ 20 %) and calculate dose reduction-free survival among the arms of the study;
Time Frame
3 months
Title
Hospitalizations
Description
To compare the number of hospitalizations among the arms of the study;
Time Frame
3 months
Title
Infections
Description
To compare the number of infections (any grade) among the arms of the study.
Time Frame
3 months
Title
Use of anti-microbials
Description
To compare the number of patients that used anti-microbials among the arms of the study.
Time Frame
3 months
Title
Use of G-CSF
Description
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
Title
Incidence of febrile neutropenia
Description
To compare the incidence of febrile neutropenia among the arms of the study.
Time Frame
3 months
Title
ECOG-PS worsening-free survival
Description
To compare worsening-free survival of the ECOG-PS (> 1 point) among the arms of the study
Time Frame
Along the study (3 months)
Title
Nutritional status
Description
To compare nutritional status among the arms of the study
Time Frame
Along the study (3 months)
Title
Antineoplastic response rates
Description
To compare antineoplastic response rates among the arms of the study
Time Frame
3 months
Title
Progression-free survival
Description
To compare progression-free survival among the arms of the study
Time Frame
3 months
Title
Adherence to AferBio®
Description
To assess adherence to treatment with AferBio®
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos E Paiva, MD, PhD
Phone
+551733216600
Ext
6786
Email
caredupai@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bianca SR Paiva, RN, PhD
Phone
+551733216600
Email
bsrpaiva@gmail.com
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
SP
ZIP/Postal Code
14784400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Paiva, PhD
Phone
1733216600
First Name & Middle Initial & Last Name & Degree
Bianca Paiva, PhD
Phone
1733216600

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31023257
Citation
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.
Results Reference
derived

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

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