Effects of Mediterranean Diet and naltrexone/bupropion treatment in overweight and obese breast cancer patients

Not Applicable

Completed

Conditions: Endocrine, nutritional and metabolic disease

Registration Number: KCT0003142

Lead Sponsor: Yonsei University Health System, Gangnam Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in body weight

Secondary Outcome Measures

Name	Time	Method
Change in body composition (fat mass, muscle mass);Change in inflammatory markers (leukocyte count);Change in metabolic risk factors (fasting glucose, insulin, triglyceride, HDL-cholesterol)