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

• Status: Completed
• Trial end date: 2018-07-22
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gangnam Severance Hospital
• Treatments: Bupropion; Naltrexone

Criteria

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