Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05968677
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-07-03
Brief Title:
Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity Nutritional Status and Quality of Life in Breast Cancer Patients
Sponsor:
Flavolife Srl
Organization:
Flavolife Srl
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None