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

Flavolife

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Nutritional counseling; Dietary Supplement: FSMP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05968677

SELECT-BC

Details and patient eligibility

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

FSMP

Experimental group

Description:

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)

Treatment:

Other: Nutritional counseling

Dietary Supplement: FSMP

Control

Other group

Description:

Nutritional counseling

Treatment:

Other: Nutritional counseling