Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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