RecruitingNot ApplicableNCT05968677

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


Sponsor

Flavolife Srl

Enrollment

60 participants

Start Date

Aug 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a specialized nutritional supplement — containing amino acids and flavonoids (plant-based compounds) — can help reduce the side effects of chemotherapy, support nutrition, and improve quality of life in women with breast cancer. Participants are post-menopausal women with non-metastatic breast cancer who are receiving specific types of chemotherapy. **You may be eligible if...** - You are a post-menopausal woman with a confirmed diagnosis of non-metastatic breast cancer (ductal type) - You are scheduled to receive chemotherapy containing doxorubicin or epirubicin, with or without cyclophosphamide, either before or after surgery - You are able to eat and drink normally without tube feeding - You are well enough to attend regular clinic visits **You may NOT be eligible if...** - You are being fed through a tube or intravenously - Your overall health is significantly reduced (ECOG performance status greater than 2) - You have another active cancer diagnosis - You have previously received doxorubicin or epirubicin - You are currently receiving targeted molecular therapies - You have a history of chronic kidney, liver, or heart disease - You have a known allergy to any ingredient in the study supplement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTFSMP

Food for Special Medical Purposes specifically formulated for the dietary management of malnourished patients following therapeutic treatments such as chemo and radiotherapy

OTHERNutritional 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

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NCT05968677


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