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

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Breast Cancer; Overweight; Obesity

Treatments: Behavioral: Mediterranean Diet; Drug: naltrexone/bupropion

Study type: Interventional

Funder types: Other

Identifiers

NCT03581630

3-2017-0097

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet

Experimental group

Treatment:

Behavioral: Mediterranean Diet

Drug: naltrexone/bupropion

Breast cancer subjects-Mediterranean Diet

Experimental group

Treatment:

Behavioral: Mediterranean Diet

Healthy subjects-naltrexone/bupropion+Mediterranean Diet

Active Comparator group

Treatment:

Behavioral: Mediterranean Diet

Drug: naltrexone/bupropion