Metabolic Parameters and Quality of Life in Women on Neo-/Adjuvant Therapy for Breast Cancer: a Randomized Controlled Trial on the Effectiveness of an Intensive Dietary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Body weight control
研究概览
简要总结
The present trial aims to compare the effectiveness of an "intensive" vs a "standard" nutritional intervention on body weight regulation and some metabolic parameters in women on adjuvant/neoadjuvant therapy for breast cancer.
详细描述
The effectiveness of an "intensive" versus "non-intensive" dietary intervention will be assessed in 120 patients on adjuvant therapy for breast cancer (BC) in a prospective, randomized controlled study for a total of 3 years. The eligibility of participants will be verified according to the inclusion/exclusion criteria at the screening visit; therefore, after a detailed explanation of the study protocol, Informed Consent will be signed. After the recruitment, subjects will be randomized into an "intensive" (ARM A) and "non-intensive" (ARM B) dietary intervention group. After the 6 month treatment period, patients will be followed up for the following 18 months.
ARM A: Visits will be set up monthly in order to assess body weight, waist circumference, diet compliance (etc...) for all period of the BC adjuvant treatment (6 months).
ARM B: Visits will be set up only at the baseline, after 6 months namely at the end.
No drug treatment will be given to patients during the trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥18 years old
- •BMI < 30 kg/m2
- •Caucasians
- •Histological diagnosis of invasive breast cancer
- •Starting an adjuvant systemic treatment for breast cancer
- •Available past medical history
- •Informed consent to participate to the study
排除标准
- •Metastatic disease
- •BMI >30 kg/m2
- •Presence of a serious medical condition that could alter food absorption or prognosis
- •Refusal to provide informed consent to participate in the study
研究组 & 干预措施
ARM A: intensive nutritional intervention
ARM A: Visits will be set up monthly in order to assess body weight, waist circumference, diet compliance (etc...) for all period of the BC adjuvant treatment (6 months).
干预措施: Nutritional counseling. No drug treatment will be administered in this study. (Behavioral)
ARM B: standard nutritional intervention
ARM B: Visits will be set up only at the baseline, after 6 months namely at the end
结局指标
主要结局
Body weight control
时间窗: 12 months
To investigate the effects of an intensive nutritional intervention on Body weight control (defined as weight changes ≤+5% of the initial body weight) at 12 months after the beginning of systemic treatment.
Body weight control
时间窗: 12 months
To investigate the effects of an intensive nutritional intervention on Body weight control (defined as weight changes ≤+5% of the initial body weight) at 12 months after the beginning of systemic treatment.
次要结局
- Change from Baseline in the Mean concentration of urate(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Aspartate Amino Transaminase(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Alanine AminoTransferase(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Gamma-Glutamyl Transferase(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Alkaline Phosphatase(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of erythrocytes Sedimentation Rate(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of C-reactive protein(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Thyroid-stimulating hormone(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Free Triiodothyronine(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Free thyroxine(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of LDL cholesterol(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of triglycerides(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of urea(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of vitamin D(From enrollment to 6,12 and 24 months)
- Body Mass Index (BMI)(From enrollment to 6, 12 and 24 months)
- Body composition(From enrollment to 6, 12 and 24 months)
- Resting energy expenditure (REE)(From enrollment to 6, 12 and 24 months)
- Quality of life (QoL)(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Fasting glucose(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Serum insulin (mg/dl)(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of C-peptide (ng/ml)(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of glycosylated haemoglobin(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of total cholesterol(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of creatinine(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Free Triiodothyronine(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Aspartate Amino Transaminase(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of erythrocytes Sedimentation Rate(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of LDL cholesterol(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of triglycerides(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of creatinine(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of urate(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Free thyroxine(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of vitamin D(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of total cholesterol(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Alanine AminoTransferase(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Alkaline Phosphatase(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of C-reactive protein(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Thyroid-stimulating hormone(From enrollment to 6,12 and 24 months)
- Body composition(From enrollment to 6, 12 and 24 months)
- Body weight(From enrollment to 6, 12 and 24 months)
- Body Mass Index (BMI)(From enrollment to 6, 12 and 24 months)
- Resting energy expenditure (REE)(From enrollment to 6, 12 and 24 months)
- Quality of life (QoL)(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Serum insulin (mg/dl)(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of C-peptide (ng/ml)(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of glycosylated haemoglobin(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of HDL cholesterol(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Fasting glucose(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of urea(From enrollment to 6,12 and 24 months)
- Change from Baseline in the Mean concentration of Gamma-Glutamyl Transferase(From enrollment to 6,12 and 24 months)
研究者
Grazia Arpino
Principal Investigator
Federico II University