Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
Breast Cancer
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, flavonoids, aminoacids, nutrition
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
Sites / Locations
- IRCSS San Matteo University Hospital FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
FSMP
Control
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)
Nutritional counseling