Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FSMP, Nutritional counseling.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 50 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Dietary supplement FSMP
Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy - Other Nutritional counseling
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
Primary outcome measures
- Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity [Time frame: 0, 6, 12 weeks]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- IRCSS San Matteo University Hospital Foundation — Pavia
Identifiers
NCT: NCT05968677 · SELECT-BC