Clinical trial NCT03469063: Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients
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
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Infection
Drug Toxicity
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Health-related QOL scores over time.
timeFrame: Over time (during 90 days)
Secondary outcomes:
measure: Toxicity
timeFrame: 3 months
measure: 20% reduction in HRQOL
timeFrame: Along the study (3 months)
measure: Treatment delays
timeFrame: 3 months
measure: Dose intensity
timeFrame: 3 months
measure: Dose-reduction rates
timeFrame: 3 months
measure: Hospitalizations
timeFrame: 3 months
measure: Infections
timeFrame: 3 months
measure: Use of anti-microbials
timeFrame: 3 months
measure: Use of G-CSF
timeFrame: 3 months
measure: Incidence of febrile neutropenia
timeFrame: 3 months
measure: ECOG-PS worsening-free survival
timeFrame: Along the study (3 months)
measure: Nutritional status
timeFrame: Along the study (3 months)
measure: Antineoplastic response rates
timeFrame: 3 months
measure: Progression-free survival
timeFrame: 3 months
measure: Adherence to AferBio®
timeFrame: 3 months
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: SP
Study officials:
References:
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.