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

NCT ID: NCT05968677

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2026-08-31

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.

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 inclusion and exclusion criteria, will propose patient to participate in the study and, after obtaining informed consent, will proceed with enrollment. On the first day of chemotherapy, participants will undergo an oncological and nutritional examination, with collection of anthropometric data, assessment of body composition, assessment of quality of life through special validated questionnaires, blood sampling for blood chemistry tests and urine collection. Participants in the treated group will receive a supply of the FSMP to take home. At check-up visits, the participant's nutritional status and any adverse events will be assessed, other than adherence to treatment by delivery of empty product boxes and chemotherapy compliance. Blood chemistry tests will be repeated at 6 weeks after the first chemotherapy cycle and 3 weeks after the last chemotherapy cycle (follow-up period).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

FSMP

Intervention Type: DIETARY_SUPPLEMENT

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

Nutritional counseling

Intervention Type: 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

Nutritional counseling

Group Type: OTHER

Nutritional counseling

Intervention Type: 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

Interventions

FSMP

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Flavolife Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Pedrazzoli, MD

Role: PRINCIPAL_INVESTIGATOR

Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation

Locations

IRCSS San Matteo University Hospital Foundation

Pavia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Pedrazzoli, MD

Role: CONTACT

p.pedrazzoli@smatteo.pv.it

+390382501659

Emanuele Cereda, MD

Role: CONTACT

e.cereda@smatteo.pv.it

Facility Contacts

Paolo Pedrazzoli, MD

Role: primary

p.pedrazzoli@smatteo.pv.it

+390382501659

Emanuele Cereda, MD

Role: backup

e.cereda@smatteo.pv.it

Other Identifiers

SELECT-BC

Identifier Type: -

Identifier Source: org_study_id