Status:
RECRUITING
Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
Lead Sponsor:
Flavolife Srl
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-70 years
Phase:
NA
Brief 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 n...
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05968677
Start Date
August 4 2023
End Date
August 1 2026
Last Update
March 14 2025
Active Locations (1)
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1
IRCSS San Matteo University Hospital Foundation
Pavia, Italy