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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 50
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCSS San Matteo University Hospital Foundation
RECRUITING
Pavia
Contact Information
Primary
Paolo Pedrazzoli, MD
p.pedrazzoli@smatteo.pv.it
+390382501659
Backup
Emanuele Cereda, MD
e.cereda@smatteo.pv.it
Time Frame
Start Date: 2023-08-04
Estimated Completion Date: 2026-08
Participants
Target number of participants: 60
Treatments
Experimental: FSMP
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)
Other: Control
Nutritional counseling
Related Therapeutic Areas
Sponsors
Leads: Flavolife Srl

This content was sourced from clinicaltrials.gov