Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
- Conditions
- OverweightBreast CancerObesity
- Interventions
- Drug: naltrexone/bupropionBehavioral: Mediterranean Diet
- Registration Number
- NCT03581630
- Lead Sponsor
- Gangnam Severance Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet naltrexone/bupropion - Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet Mediterranean Diet - Breast cancer subjects-Mediterranean Diet Mediterranean Diet - Healthy subjects-naltrexone/bupropion+Mediterranean Diet naltrexone/bupropion - Healthy subjects-naltrexone/bupropion+Mediterranean Diet Mediterranean Diet -
- Primary Outcome Measures
Name Time Method Change in body weight baseline, 8 weeks body weight (kg)
Change in fat mass baseline, 8 weeks fat mass (kg) measured by bioelectrical impedance analyzer
Change in muscle mass baseline, 8 weeks muscle mass (kg) measured by bioelectrical impedance analyzer
Change in fasting glucose baseline, 8 weeks fasting glucose (mg/dL)
Change in insulin baseline, 8 weeks insulin (mcIU/mL)
Change in high-density lipoprotein cholesterol (HDL-cholesterol) baseline, 8 weeks HDL-cholesterol (mg/dL)
Change in leukocyte count baseline, 8 weeks leukocyte count (/μL)
Change in triglyceride baseline, 8 weeks triglyceride (mg/dL)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GangnamSeverance Hospital
🇰🇷Seoul, Korea, Republic of