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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
72
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.
Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
GangnamSeverance Hospital
Seoul, South Korea
Change in body weight
body weight (kg)
Time frame: baseline, 8 weeks
Change in fat mass
fat mass (kg) measured by bioelectrical impedance analyzer
Time frame: baseline, 8 weeks
Change in muscle mass
muscle mass (kg) measured by bioelectrical impedance analyzer
Time frame: baseline, 8 weeks
Change in fasting glucose
fasting glucose (mg/dL)
Time frame: baseline, 8 weeks
Change in insulin
insulin (mcIU/mL)
Time frame: baseline, 8 weeks
Change in triglyceride
triglyceride (mg/dL)
Time frame: baseline, 8 weeks
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
HDL-cholesterol (mg/dL)
Time frame: baseline, 8 weeks
Change in leukocyte count
leukocyte count (/μL)
Time frame: baseline, 8 weeks
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