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

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ClinicalTrials.gov Identifier: NCT03469063
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Quality of Life Infection Drug Toxicity Dietary Supplement: AferBio Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : June 28, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 3 months ]
    To compare the incidence of any given toxicity ≥ grade 3 (jointly and individually)

  2. 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;

  3. 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;

  4. Dose intensity [ Time Frame: 3 months ]
    To compare the dose intensity (in mg/m2/week) among the arms of the study

  5. 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;

  6. Hospitalizations [ Time Frame: 3 months ]
    To compare the number of hospitalizations among the arms of the study;

  7. Infections [ Time Frame: 3 months ]
    To compare the number of infections (any grade) among the arms of the study.

  8. Use of anti-microbials [ Time Frame: 3 months ]
    To compare the number of patients that used anti-microbials among the arms of the study.

  9. 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.

  10. Incidence of febrile neutropenia [ Time Frame: 3 months ]
    To compare the incidence of febrile neutropenia among the arms of the study.

  11. 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

  12. Nutritional status [ Time Frame: Along the study (3 months) ]
    To compare nutritional status among the arms of the study

  13. Antineoplastic response rates [ Time Frame: 3 months ]
    To compare antineoplastic response rates among the arms of the study

  14. Progression-free survival [ Time Frame: 3 months ]
    To compare progression-free survival among the arms of the study

  15. Adherence to AferBio® [ Time Frame: 3 months ]
    To assess adherence to treatment with AferBio®



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469063


Contacts
Contact: Carlos E Paiva, MD, PhD +551733216600 ext 6786 caredupai@gmail.com
Contact: Bianca SR Paiva, RN, PhD +551733216600 bsrpaiva@gmail.com

Locations
Brazil
Barretos Cancer Hospital Recruiting
Barretos, SP, Brazil, 14784400
Contact: Carlos Paiva, PhD    1733216600      
Contact: Bianca Paiva, PhD    1733216600      
Sponsors and Collaborators
Barretos Cancer Hospital

Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT03469063     History of Changes
Other Study ID Numbers: BarretosCH-20174
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders