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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:
Researchers will compare a similar group of participants only receiving the nutritional counseling to see if any difference occurs.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Control | Other | Nutritional counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FSMP | Dietary Supplement | Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0, 6, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0, 3, 6, 9, 12 weeks |
| Mean change from baseline in Phase Angle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Pedrazzoli, MD | Contact | +390382501659 | p.pedrazzoli@smatteo.pv.it | |
| Emanuele Cereda, MD | Contact | e.cereda@smatteo.pv.it |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Pedrazzoli, MD | Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCSS San Matteo University Hospital Foundation | Recruiting | Pavia | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Nutritional counseling | Other | 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 |
|
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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 0, 12 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |