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

June 13, 2018 updated by: Barretos Cancer Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health-related QOL scores over time.
Time Frame: Over time (during 90 days)
To compare health-related QOL scores among the arms of the study over time.
Over time (during 90 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: 3 months
To compare the incidence of any given toxicity ≥ grade 3 (jointly and individually)
3 months
20% reduction in HRQOL
Time Frame: Along the study (3 months)
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
Time Frame: 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;
3 months
Dose intensity
Time Frame: 3 months
To compare the dose intensity (in mg/m2/week) among the arms of the study
3 months
Dose-reduction rates
Time Frame: 3 months
To compare dose-reduction rates (≥ 20 %) and calculate dose reduction-free survival among the arms of the study;
3 months
Hospitalizations
Time Frame: 3 months
To compare the number of hospitalizations among the arms of the study;
3 months
Infections
Time Frame: 3 months
To compare the number of infections (any grade) among the arms of the study.
3 months
Use of anti-microbials
Time Frame: 3 months
To compare the number of patients that used anti-microbials among the arms of the study.
3 months
Use of G-CSF
Time Frame: 3 months
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
Time Frame: 3 months
To compare the incidence of febrile neutropenia among the arms of the study.
3 months
ECOG-PS worsening-free survival
Time Frame: Along the study (3 months)
To compare worsening-free survival of the ECOG-PS (> 1 point) among the arms of the study
Along the study (3 months)
Nutritional status
Time Frame: Along the study (3 months)
To compare nutritional status among the arms of the study
Along the study (3 months)
Antineoplastic response rates
Time Frame: 3 months
To compare antineoplastic response rates among the arms of the study
3 months
Progression-free survival
Time Frame: 3 months
To compare progression-free survival among the arms of the study
3 months
Adherence to AferBio®
Time Frame: 3 months
To assess adherence to treatment with AferBio®
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Barretos Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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