Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment on Body Weight and Metabolic Risk Factors in Obese Breast Cancer Patients After Breast Cancer Treatment

Conditions
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Breast Cancer, Obesity, Overweight

Intervention / Treatment
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* Drug: naltrexone/bupropion
* Behavioral: Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet<br> | Drug: naltrexone/bupropion<br>* Naltrexone hydrochloride (HCl) 8 mg/Bupropion hydrochloride (HCl) 90 mg extended release (ER) combination tablets, orally, one tablet, in the morning, daily, for 1 week, followed by Naltrexone HCl 8 mg/Bupropion HCl 90 mg ER combination tablets, orally, one tablet in the morning and one in the evening, daily, for 7 weeks.<br>Behavioral: Mediterranean Diet<br>* Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.<br>|
| Experimental: Breast cancer subjects-Mediterranean Diet<br> | Behavioral: Mediterranean Diet<br>* Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.<br>|
| Active Comparator: Healthy subjects-naltrexone/bupropion+Mediterranean Diet<br> | Drug: naltrexone/bupropion<br>* Naltrexone hydrochloride (HCl) 8 mg/Bupropion hydrochloride (HCl) 90 mg extended release (ER) combination tablets, orally, one tablet, in the morning, daily, for 1 week, followed by Naltrexone HCl 8 mg/Bupropion HCl 90 mg ER combination tablets, orally, one tablet in the morning and one in the evening, daily, for 7 weeks.<br>Behavioral: Mediterranean Diet<br>* Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | body weight (kg) | baseline, 8 weeks | 
| Change in fat mass | fat mass (kg) measured by bioelectrical impedance analyzer | baseline, 8 weeks | 
| Change in muscle mass | muscle mass (kg) measured by bioelectrical impedance analyzer | baseline, 8 weeks | 
| Change in fasting glucose | fasting glucose (mg/dL) | baseline, 8 weeks | 
| Change in insulin | insulin (mcIU/mL) | baseline, 8 weeks | 
| Change in triglyceride | triglyceride (mg/dL) | baseline, 8 weeks | 
| Change in high-density lipoprotein cholesterol (HDL-cholesterol) | HDL-cholesterol (mg/dL) | baseline, 8 weeks | 
| Change in leukocyte count | leukocyte count (/μL) | baseline, 8 weeks |