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

NCT05968677 | Recruiting

• 1 other identifier: SELECT-BC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Breast Cancer

Keywords

breast cancer; flavonoids; aminoacids; nutrition

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity

  The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model

  0, 6, 12 weeks

Secondary Outcomes (8)

• Mean change from baseline in weight, Body Mass Index (BMI) and Fat Free Mass Index (FFMI)

  0, 3, 6, 9, 12 weeks

• Mean change from baseline in Phase Angle

  0, 3, 6, 9, 12 weeks

• Mean change from baseline in Bioelectrical Impedance Vector Analysis (BIVA)

  0, 3, 6, 9, 12 weeks

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  3, 6, 9, 12 weeks

• Mean change from baseline in Interleukine-6 levels

  0, 6, 12 weeks

Study Arms (2)

FSMP

EXPERIMENTAL

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)

Dietary Supplement: FSMP; Other: Nutritional counseling

Control

OTHER

Nutritional counseling

Other: Nutritional counseling

Interventions

FSMP DIETARY_SUPPLEMENT

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

FSMP

Nutritional counseling OTHER

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

Control; FSMP

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flavolife Srl: lead

Study Sites (1)

IRCSS San Matteo University Hospital Foundation

Pavia, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Paolo Pedrazzoli, MD

  Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Pedrazzoli, MD

CONTACT

+390382501659; p.pedrazzoli@smatteo.pv.it

Emanuele Cereda, MD

CONTACT

e.cereda@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 1, 2023
• Study Start: August 4, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

IT (1)