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

NCT03469063 | Unknown

• 1 other identifier: BarretosCH-20174
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Infection; Drug Toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Toxicity

  3 months

• 20% reduction in HRQOL

  Along the study (3 months)

• Treatment delays

  3 months

• Dose intensity

  3 months

• Dose-reduction rates

  3 months

Study Arms (2)

AferBio

EXPERIMENTAL

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

Dietary Supplement: AferBio

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: AferBio

Interventions

AferBio DIETARY_SUPPLEMENT

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).

AferBio; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 31023257 DERIVED

MeSH Terms

Conditions

Infections; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Central Study Contacts

Carlos E Paiva, MD, PhD

CONTACT

+551733216600; caredupai@gmail.com

Bianca SR Paiva, RN, PhD

CONTACT

+551733216600; bsrpaiva@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 19, 2018
• Study Start: June 28, 2018
• Primary Completion: February 28, 2020
• Study Completion: June 30, 2020
• Last Updated: June 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)