Clinical trial NCT05968677: Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
flavonoids
aminoacids
nutrition
Lead sponsor: Flavolife Srl
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity
timeFrame: 0, 6, 12 weeks
Secondary outcomes:
measure: Mean change from baseline in weight, Body Mass Index (BMI) and Fat Free Mass Index (FFMI)
timeFrame: 0, 3, 6, 9, 12 weeks
measure: Mean change from baseline in Phase Angle
timeFrame: 0, 3, 6, 9, 12 weeks
measure: Mean change from baseline in Bioelectrical Impedance Vector Analysis (BIVA)
timeFrame: 0, 3, 6, 9, 12 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 3, 6, 9, 12 weeks
measure: Mean change from baseline in Interleukine-6 levels
timeFrame: 0, 6, 12 weeks
measure: Mean change from baseline Interleukine-1 beta levels
timeFrame: 0, 6, 12 weeks
measure: Mean change from baseline in C-reactive Protein levels
timeFrame: 0, 6, 12 weeks
measure: Participant's perception of her physical and mental state
timeFrame: 0, 12 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCSS San Matteo University Hospital Foundation
Study officials:
affiliation: Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation
name: Paolo Pedrazzoli, MD
role: PRINCIPAL_INVESTIGATOR
References: