Quality of LifeAFERBIONCT03469063
Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients
A study testing AferBio in people with Quality of Life and Infection, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quality of Life, Infection, Drug Toxicity
- What is being tested?
- AferBio
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jun 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Barretos Cancer Hospital
Barretos, São Paulo, 14784400
Carlos Paiva, PhD, 1733216600
Bianca Paiva, PhD, 1733216600
About this study
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
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
- Being tested
- AferBio
- Medical subject headings
- Infections, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AferBioDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| AferBio | Experimental | Daily oral AferBio (20 g/day, in sachets) Receives: Dietary Supplement: AferBio |
| Placebo | Placebo comparator | Daily oral placebo (20 g/day, in sachets) Receives: Dietary Supplement: AferBio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related QOL scores over time.
To compare health-related QOL scores among the arms of the study over time.
Measured: Over time (during 90 days)
Secondary outcomes (15)
Toxicity
To compare the incidence of any given toxicity ≥ grade 3 (jointly and individually)
Measured: 3 months
20% reduction in HRQOL
To compare worsening-free survival of 20 % of the health-related QOL scores among the arms of the study;
Measured: Along the study (3 months)
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;
Measured: 3 months
Dose intensity
To compare the dose intensity (in mg/m2/week) among the arms of the study
Measured: 3 months
Dose-reduction rates
To compare dose-reduction rates (≥ 20 %) and calculate dose reduction-free survival among the arms of the study;
Measured: 3 months
Hospitalizations
To compare the number of hospitalizations among the arms of the study;
Measured: 3 months
Infections
To compare the number of infections (any grade) among the arms of the study.
Measured: 3 months
Use of anti-microbials
To compare the number of patients that used anti-microbials among the arms of the study.
Measured: 3 months
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.
Measured: 3 months
Incidence of febrile neutropenia
To compare the incidence of febrile neutropenia among the arms of the study.
Measured: 3 months
ECOG-PS worsening-free survival
To compare worsening-free survival of the ECOG-PS (> 1 point) among the arms of the study
Measured: Along the study (3 months)
Nutritional status
To compare nutritional status among the arms of the study
Measured: Along the study (3 months)
Antineoplastic response rates
To compare antineoplastic response rates among the arms of the study
Measured: 3 months
Progression-free survival
To compare progression-free survival among the arms of the study
Measured: 3 months
Adherence to AferBio®
To assess adherence to treatment with AferBio®
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start28 Jun 2018 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469063
- Sponsor's protocol ID
- BarretosCH-20174
- Acronym
- AFERBIO
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31023257
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03469063
- Acronym / sponsor ID
- AFERBIO / BarretosCH-20174
- Conditions
- Quality of Life, Infection, Drug Toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 28 Jun 2018 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AferBio | Experimental | Dietary Supplement: AferBioDaily oral AferBio (20 g/day, in sachets) |
| Placebo | Placebo comparator | Dietary Supplement: AferBioDaily oral placebo (20 g/day, in sachets) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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:
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AferBioPatients 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). | Dietary supplement | AferBio, Placebo |
Primary outcome
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.
15 secondary outcomes
Toxicity
Time frame: 3 months
20% reduction in HRQOL
Time frame: Along the study (3 months)
Treatment delays
Time frame: 3 months
Dose intensity
Time frame: 3 months
Dose-reduction rates
Time frame: 3 months
Hospitalizations
Time frame: 3 months
Infections
Time frame: 3 months
Use of anti-microbials
Time frame: 3 months
Use of G-CSF
Time frame: 3 months
Incidence of febrile neutropenia
Time frame: 3 months
ECOG-PS worsening-free survival
Time frame: Along the study (3 months)
Nutritional status
Time frame: Along the study (3 months)
Antineoplastic response rates
Time frame: 3 months
Progression-free survival
Time frame: 3 months
Adherence to AferBio®
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Derived from this study: PubMed 31023257D'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AferBio in people with Quality of Life and Infection, run by Barretos Cancer Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos E Paiva, MD, PhD (+551733216600 ext. 6786, caredupai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related QOL scores over time. (time frame: Over time (during 90 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.