KCT0003142已完成未知
The effects of Mediterranean Diet and naltrexone/bupropion treatment on inflammation and metabolic risk factor of overweight breast cancer patients after breast cancer treatment
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 65(Year)（—）
- 性别
- Female
入选标准
- •1) Female, over 20 years of age
- •2) Diagnosed with breast cancer stage ?-?, and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy, hormonal therapy
- •3) 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)
- •4) BMI =25 kg/m2
- •5) Able to speak and read Korean
- •6) Approved to participate in the study by physician
- •7) Able to complete the study without participating in other intervention studies during the study period
- •8) If woman of child bearing potential, agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug
- •9) Participants with no limitation of physcial activity during the study period
排除标准
- •1) Female, over 65 years of age
- •2) Participants with cancer recurrence or metastasis
- •3) Participants with uncontrolled hypertension (systolic blood pressure (SBP) >180 mmHg, or diastolic blood pressure (DBP) >120 mmHg)
- •4) 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)
- •5) Participants with significant cardiovascular disease or stroke
- •6) Participants with history of seizures
- •7) Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation
- •8) Participants who are taking medications such as monoamine oxidase (MAO) inhibitors, opioid-containing medications, other naltrexone or bupropion containing medications, and Tamoxifen
- •9) Participants with alcohol abuse or dependence
- •10) Current smokers or use of nicotine replacement products in the previous 6 months
- •11) Pregnant or breast-feeding women
- •12) Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
研究者
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