Breast Cancer, Obesity, Overweight
Conditions
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.
Interventions
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.
BEHAVIORALMediterranean Diet
Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 triglyceride | baseline, 8 weeks | triglyceride (mg/dL) |
| 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) |
Countries
South Korea
Outcome results
None listed