NCT03581630

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer
• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	naltrexone/bupropion	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.
BEHAVIORAL	Mediterranean Diet	Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.

Timeline

• Start date: 2017-07-29
• Primary completion: 2018-07-22
• Completion: 2018-07-22
• First posted: 2018-07-10
• Last updated: 2018-08-29

Locations

1 site across 1 country: South Korea