Amino acids and flavonoids to reduce chemotherapy side effects 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
This study is testing if a special nutritional drink with amino acids and flavonoids can help breast cancer patients feel better and manage side effects during chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | Female |
| Sponsor | Flavolife Srl Industry-sponsored |
| Drugs / interventions | Chemotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Pavia) |
| Trial ID | NCT05968677 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of a Food for Special Medical Purposes (FSMP) containing amino acids and flavonoids, combined with nutritional counseling, on chemotherapy toxicity, nutritional status, and quality of life in breast cancer patients. Participants will be randomly assigned to receive either the FSMP along with nutritional counseling or nutritional counseling alone for 12 weeks. The study will assess various health metrics, including body composition and quality of life, through validated questionnaires and blood tests. The goal is to determine if the dietary supplementation can improve outcomes for patients undergoing chemotherapy.
Who should consider this trial
Good fit: Ideal candidates include post-menopausal women diagnosed with non-metastatic ductal breast cancer who are scheduled to receive specific chemotherapy regimens.
Not a fit: Patients who are on artificial feeding or have severe performance status or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the nutritional status and quality of life for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While similar dietary interventions have shown promise in improving patient outcomes, this specific combination of amino acids and flavonoids in breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia
- IRCSS San Matteo University Hospital Foundation — Pavia, Italy (Recruiting)
Study contacts
- Principal investigator: Paolo Pedrazzoli, MD — Unit of Medical Oncology-IRCSS San Matteo University Hospital Foundation
- Study coordinator: Paolo Pedrazzoli, MD
- Email: p.pedrazzoli@smatteo.pv.it
- Phone: +390382501659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.