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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean change from baseline in High-Sensitivity Troponin Levels as a serological marker of chemotherapy cardiotoxicity
时间窗: 0, 6, 12 weeks
The comparison of changes from baseline will be performed using a generalized linear regression model, adjusting for the baseline value of the biomarker. The difference in averages between groups and the relative range of confidence of 90 percent will be derived from the model
次要结局
- Mean change from baseline in Interleukine-6 levels(0, 6, 12 weeks)
- Mean change from baseline in weight, Body Mass Index (BMI) and Fat Free Mass Index (FFMI)(0, 3, 6, 9, 12 weeks)
- Mean change from baseline in C-reactive Protein levels(0, 6, 12 weeks)
- Participant's perception of her physical and mental state(0, 12 weeks)
- Mean change from baseline in Phase Angle(0, 3, 6, 9, 12 weeks)
- Mean change from baseline in Bioelectrical Impedance Vector Analysis (BIVA)(0, 3, 6, 9, 12 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(3, 6, 9, 12 weeks)
- Mean change from baseline Interleukine-1 beta levels(0, 6, 12 weeks)