Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment on Body Weight and Metabolic Risk Factors in Obese Breast Cancer Patients After Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
Obesity among breast cancer survivors is known to be associated with recurrence and other co-morbidities. However, there have been no studies on weight reduction program combining diet and anti-obesity drug for obese breast cancer survivors. The purpose of this randomized clinical trial is to examine the effects of Mediterranean Diet and naltrexone/bupropion treatment on inflammation and metabolic risk factors in overweight or obese breast cancer patients after breast cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 20 to 65 years of age
- •Diagnosed with breast cancer stage Ⅰ-Ⅲ, and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy, hormonal therapy
- •BMI ≥25 kg/m2, or BMI ≥23 kg/m2 with one or more of the metabolic risk factors (waist circumference ≥80 cm, fasting glucose ≥100 mg/dL, BP ≥130/85 mmHg, HDL-cholesterol <50 mg/dL or controlled diabetes, hypertension, dyslipidemia with medications)
- •If woman of child bearing potential, agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug
- •Able to speak and read Korean
- •Able to comply with all required study procedures and schedule
- •Willing and able to give written informed consent
排除标准
- •Participants with cancer recurrence or metastasis
- •Participants with uncontrolled hypertension (systolic blood pressure (SBP) >180 mmHg, or diastolic blood pressure (DBP) >120 mmHg)
- •Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 x institutional upper limit of normal) or renal disease (serum creatinine >2.0 mg/dL)
- •Participants with significant cardiovascular disease or stroke
- •Participants with history of seizures
- •Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation
- •Participants who are taking medications such as monoamine oxidase (MAO) inhibitors, opioid-containing medications, other naltrexone or bupropion containing medications, and Tamoxifen
- •Current smokers or use of nicotine replacement products in the previous 6 months
- •Pregnant or breast-feeding women
- •Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
研究组 & 干预措施
Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet
干预措施: naltrexone/bupropion (Drug)
Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet
干预措施: Mediterranean Diet (Behavioral)
Breast cancer subjects-Mediterranean Diet
干预措施: Mediterranean Diet (Behavioral)
Healthy subjects-naltrexone/bupropion+Mediterranean Diet
干预措施: naltrexone/bupropion (Drug)
Healthy subjects-naltrexone/bupropion+Mediterranean Diet
干预措施: Mediterranean Diet (Behavioral)
结局指标
主要结局
Change in body weight
时间窗: baseline, 8 weeks
body weight (kg)
Change in fat mass
时间窗: baseline, 8 weeks
fat mass (kg) measured by bioelectrical impedance analyzer
Change in muscle mass
时间窗: baseline, 8 weeks
muscle mass (kg) measured by bioelectrical impedance analyzer
Change in fasting glucose
时间窗: baseline, 8 weeks
fasting glucose (mg/dL)
Change in insulin
时间窗: baseline, 8 weeks
insulin (mcIU/mL)
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
时间窗: baseline, 8 weeks
HDL-cholesterol (mg/dL)
Change in leukocyte count
时间窗: baseline, 8 weeks
leukocyte count (/μL)
Change in triglyceride
时间窗: baseline, 8 weeks
triglyceride (mg/dL)
次要结局
未报告次要终点
研究者
Ji-Won Lee
Associate Professor (Department of Family Medicine, Gangnam Severance Hospital,
Gangnam Severance Hospital