Actively Recruiting
Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
Led by Flavolife Srl · Updated on 2025-03-14
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non-metastatic ductal breast cancer
- Post-menopausal women
- Scheduled chemotherapy with Doxorubicin or Epirubicin, with or without Cyclophosphamide, as adjuvant or neo-adjuvant
- Provided written informed consent
- Able to eat independently by mouth
- Able to attend periodic study visits
You will not qualify if you...
- Receiving artificial feeding
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- Unable to undergo required measurements
- Presence of other tumor diseases
- Previous therapy with Doxorubicin or Epirubicin
- Currently receiving molecular targeted therapies
- History of chronic kidney, liver, or heart failure
- History of mental disorders
- Known allergies or intolerances to any study product ingredient
- Participation in other interventional clinical trials within the past three months
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCSS San Matteo University Hospital Foundation
Pavia, Italy
Actively Recruiting
Research Team
P
Paolo Pedrazzoli, MD
CONTACT
E
Emanuele Cereda, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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