Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
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
Flavolife Srl
60 participants
Aug 4, 2023
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
Interventions
Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05968677