RECRUITINGINTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Independent oral feeding - Must be able to carry out periodic visits Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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

Locations (1)

IRCSS San Matteo University Hospital Foundation

Pavia, Italy