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Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients

NCT05968677 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

FSMP

Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy

OTHER

Nutritional counseling

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

Sponsors & Collaborators

  • Flavolife Srl

    lead INDUSTRY

Principal Investigators

  • Paolo Pedrazzoli, MD · Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2026-01-31
Completion
2026-08-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05968677 on ClinicalTrials.gov