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Trial Title:
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
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
flavonoids
aminoacids
nutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
FSMP
Description:
Food for Special Medical Purposes specifically formulated for the dietary management of
malnourished patients following therapeutic treatments such as chemo and radiotherapy
Arm group label:
FSMP
Intervention type:
Other
Intervention name:
Nutritional counseling
Description:
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
Arm group label:
Control
Arm group label:
FSMP
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).
Criteria for 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
Gender:
Female
Minimum age:
50 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCSS San Matteo University Hospital Foundation
Address:
City:
Pavia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo Pedrazzoli, MD
Phone:
+390382501659
Email:
p.pedrazzoli@smatteo.pv.it
Contact backup:
Last name:
Emanuele Cereda, MD
Email:
e.cereda@smatteo.pv.it
Investigator:
Last name:
Paolo Pedrazzoli, MD
Email:
Principal Investigator
Investigator:
Last name:
Riccardo Caccialanza, MD
Email:
Sub-Investigator
Investigator:
Last name:
Emanuele Cereda, MD
Email:
Sub-Investigator
Investigator:
Last name:
Elisa Ferraris, MD
Email:
Sub-Investigator
Investigator:
Last name:
Lorenzo Perrone, MD
Email:
Sub-Investigator
Investigator:
Last name:
Valentina Da Prat, MD
Email:
Sub-Investigator
Start date:
August 4, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Flavolife Srl
Agency class:
Industry
Source:
Flavolife Srl
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05968677
