Breast CancerNCT05968677
Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
A study testing FSMP and Nutritional counseling in people with Breast Cancer, run by Flavolife Srl at 1 site in Italy.
Trial summary
The goal of this clinical trial is to compare the effect of a Food for Special Medical Purposes (FSMP) mainly containing amino acids and flavonoids in combination with nutritional counseling, versus nutritional counseling alone, on chemotherapy toxicity, nutritional status and quality of life in patients with breast… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FSMP and Nutritional counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 4 Aug 2023to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of non-metastatic ductal breast cancer
- Post-menopausal women
- Chemotherapy with Doxorubicin or Epirubicin, with or without Cyclophosphamide, scheduled as adjuvant or neo-adjuvant
- Written informed consent
- Independent oral feeding
- Must be able to carry out periodic visits
Who cannot join
- Artificial feeding
- Eastern Cooperative Oncology Group (ECOG) performance status >2
- Impossibility to take the foreseen measurements
- Other tumor pathologies
- Previous therapy with Doxorubicin or Epirubicin
- Ongoing treatment with molecular targeted therapies
Show all 10Show fewer
- Previous chronic renal, hepatic or cardiac insufficiency
- History of mental disorders
- Known allergies or intolerances to any study product ingredient
- Participation in other interventional clinical trials in the past three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emanuele Cereda, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCSS San Matteo University Hospital Foundation
Pavia
Paolo Pedrazzoli, MD, +390382501659, p.pedrazzoli@smatteo.pv.it
Emanuele Cereda, MD, e.cereda@smatteo.pv.it
About this study
Official title: Pragmatic, Controlled, Single-Center, Randomized Clinical Trial to Evaluate the Effect of Supplementation With an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
The goal of this clinical trial is to compare the effect of a Food for Special Medical Purposes (FSMP) mainly containing amino acids and flavonoids in combination with nutritional counseling, versus nutritional counseling alone, on chemotherapy toxicity, nutritional status and quality of life in patients with breast cancer.
The main questions it aims to answer are:
Read more
- can this dietary supplementation affect the nutritional status of breast cancer patients?
- can this dietary supplementation have any beneficial effect on chemotoxicity? Participants will be asked to undergo nutritional counseling and to take the study product every day for 12 weeks.
Researchers will compare a similar group of participants only receiving the nutritional counseling to see if any difference occurs.
Read the detailed description
Participants will be selected at the first oncological visit at the Outpatient Clinics or the Department of Medical Oncology of the IRCCS Policlinico San Matteo of Pavia. The doctor, evaluated the inclusion and exclusion criteria, will propose patient to participate in the study and, after obtaining informed consent, will proceed with enrollment. On the first day of chemotherapy, participants will undergo an oncological and nutritional examination, with collection of anthropometric data, assessment of body composition, assessment of quality of life through special validated questionnaires, blood sampling for blood chemistry tests and urine collection. Participants in the treated group will receive a supply of the FSMP to take home. At check-up visits, the participant's nutritional status and any adverse events will be assessed, other than adherence to treatment by delivery of empty product boxes and chemotherapy compliance. Blood chemistry tests will be repeated at 6 weeks after the first chemotherapy cycle and 3 weeks after the last chemotherapy cycle (follow-up period).
- Conditions
- Breast Cancer
- Being tested
- FSMP, Nutritional counseling
- Keywords
- breast cancer, flavonoids, aminoacids, nutrition
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSMPDietary supplement
Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy
Nutritional counselingOther
Participant's nutritional status will be evaluated, anthropometric data will be collected (weight, height, BMI), body composition will be evaluated (FFMI, BIVA) and a food diary will be compiled
| Study group | Role | What they receive |
|---|---|---|
| FSMP | Experimental | Nutritional counseling plus one sachet of the study product (6.5 g) per day, away from meals, starting the day after the first chemotherapy cycle until three weeks after the last chemotherapy cycle (for a total of 12 weeks) Receives: Dietary Supplement: FSMP; Other: Nutritional counseling |
| Control | Other | Nutritional counseling Receives: Other: Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity
The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
Measured: 0, 6, 12 weeks
Secondary outcomes (8)
Mean change from baseline in weight, Body Mass Index (BMI) and Fat Free Mass Index (FFMI)
Participant's weight in kilograms and height in meters will be combined to report BMI and FFMI in kg/m^2
Measured: 0, 3, 6, 9, 12 weeks
Mean change from baseline in Phase Angle
Participant's body composition will be evaluated through measurement of the phase angle which represents the relationship between resistance and capacitive reactance of the body and bioimpedance diagnostics
Measured: 0, 3, 6, 9, 12 weeks
Mean change from baseline in Bioelectrical Impedance Vector Analysis (BIVA)
Participant's water and nutritional status will be evaluated
Measured: 0, 3, 6, 9, 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Proportion of participants with adverse events of any type and specifically haematological, cardiac, gastrointestinal, hepatobiliary, metabolic, psychiatric, renal and urinary types, distinguishing between grade 1-2, grade 3-4 and grade 5.
Furthermore, the proportion of participants who discontinue chemotherapy treatment and the change in the number of participants who reduce their chemotherapy dose during the treatment
Measured: 3, 6, 9, 12 weeks
Mean change from baseline in Interleukine-6 levels
The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
Measured: 0, 6, 12 weeks
Mean change from baseline Interleukine-1 beta levels
The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
Measured: 0, 6, 12 weeks
Mean change from baseline in C-reactive Protein levels
The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
Measured: 0, 6, 12 weeks
Participant's perception of her physical and mental state
Comparison of the total average values resulting from the compilation of two validated oncological questionnaires, which include questions with scores from 1 to 4, where in general higher scores mean a worse outcome
Measured: 0, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start4 Aug 2023
- Primary completionJan 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flavolife Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Pedrazzoli, MD, Principal investigator, Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968677
- Sponsor's protocol ID
- SELECT-BC
- Status last verified
- Mar 2025
- First submitted
- 3 Jul 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic, Controlled, Single-Center, Randomized Clinical Trial to Evaluate the Effect of Supplementation With an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05968677
- Acronym / sponsor ID
- SELECT-BC
- Conditions
- Breast Cancer
- Keywords
- breast cancer, flavonoids, aminoacids, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Flavolife SrlIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 Aug 2023 (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 goal of this clinical trial is to compare the effect of a Food for Special Medical Purposes (FSMP) mainly containing amino acids and flavonoids in combination with nutritional counseling, versus nutritional counseling alone, on chemotherapy toxicity, nutritional status and quality of life in patients with breast cancer.
The main questions it aims to answer are:
- can this dietary supplementation affect the nutritional status of breast cancer patients?
- can this dietary supplementation have any beneficial effect on chemotoxicity? Participants will be asked to undergo nutritional counseling and to take the study product every day for 12 weeks.
Researchers will compare a similar group of participants only receiving the nutritional counseling to see if any difference occurs.
Detailed description
Participants will be selected at the first oncological visit at the Outpatient Clinics or the Department of Medical Oncology of the IRCCS Policlinico San Matteo of Pavia. The doctor, evaluated the inclusion and exclusion criteria, will propose patient to participate in the study and, after obtaining informed consent, will proceed with enrollment. On the first day of chemotherapy, participants will undergo an oncological and nutritional examination, with collection of anthropometric data, assessment of body composition, assessment of quality of life through special validated questionnaires, blood sampling for blood chemistry tests and urine collection. Participants in the treated group will receive a supply of the FSMP to take home. At check-up visits, the participant's nutritional status and any adverse events will be assessed, other than adherence to treatment by delivery of empty product boxes and chemotherapy compliance. Blood chemistry tests will be repeated at 6 weeks after the first chemotherapy cycle and 3 weeks after the last chemotherapy cycle (follow-up period).
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 |
|---|---|---|
| FSMP | Experimental | Dietary Supplement: FSMP, Other: Nutritional counselingNutritional counseling plus one sachet of the study product (6.5 g) per day, away from meals, starting the day after the first chemotherapy cycle until three weeks after the last chemotherapy cycle (for a total of 12 weeks) |
| Control | Other | Other: Nutritional counselingNutritional counseling |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of non-metastatic ductal breast cancer
- Post-menopausal women
- Chemotherapy with Doxorubicin or Epirubicin, with or without Cyclophosphamide, scheduled as adjuvant or neo-adjuvant
- Written informed consent
- Independent oral feeding
Key exclusion criteria (10 listed)
- Artificial feeding
- Eastern Cooperative Oncology Group (ECOG) performance status >2
- Impossibility to take the foreseen measurements
- Other tumor pathologies
- Previous therapy with Doxorubicin or Epirubicin
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 |
|---|---|---|
| FSMPFood for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy | Dietary supplement | FSMP |
| Nutritional counselingParticipant's nutritional status will be evaluated, anthropometric data will be collected (weight, height, BMI), body composition will be evaluated (FFMI, BIVA) and a food diary will be compiled | Other | Control, FSMP |
Primary outcome
Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity
Time frame: 0, 6, 12 weeks
The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
8 secondary outcomes
Mean change from baseline in weight, Body Mass Index (BMI) and Fat Free Mass Index (FFMI)
Time frame: 0, 3, 6, 9, 12 weeks
Mean change from baseline in Phase Angle
Time frame: 0, 3, 6, 9, 12 weeks
Mean change from baseline in Bioelectrical Impedance Vector Analysis (BIVA)
Time frame: 0, 3, 6, 9, 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 3, 6, 9, 12 weeks
Mean change from baseline in Interleukine-6 levels
Time frame: 0, 6, 12 weeks
Mean change from baseline Interleukine-1 beta levels
Time frame: 0, 6, 12 weeks
Mean change from baseline in C-reactive Protein levels
Time frame: 0, 6, 12 weeks
Participant's perception of her physical and mental state
Time frame: 0, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Emanuele Cereda, MD contact
Paolo Pedrazzoli, MD principal investigator
Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FSMP and Nutritional counseling in people with Breast Cancer, run by Flavolife Srl at 1 site in Italy.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. 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 Italy. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pedrazzoli, MD (+390382501659, p.pedrazzoli@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity (time frame: 0, 6, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2025.