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

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 Overview

• Status: Completed
• Conditions: Obesity; Breast Cancer; Overweight
• Intervention / Treatment: Drug: naltrexone/bupropion; Behavioral: Mediterranean Diet

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • GangnamSeverance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet	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.
EXPERIMENTAL: Breast cancer subjects-Mediterranean Diet	Behavioral: Mediterranean Diet; Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
ACTIVE_COMPARATOR: Healthy subjects-naltrexone/bupropion+Mediterranean Diet	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	body weight (kg)	baseline, 8 weeks
Change in fat mass	fat mass (kg) measured by bioelectrical impedance analyzer	baseline, 8 weeks
Change in muscle mass	muscle mass (kg) measured by bioelectrical impedance analyzer	baseline, 8 weeks
Change in fasting glucose	fasting glucose (mg/dL)	baseline, 8 weeks
Change in insulin	insulin (mcIU/mL)	baseline, 8 weeks
Change in triglyceride	triglyceride (mg/dL)	baseline, 8 weeks
Change in high-density lipoprotein cholesterol (HDL-cholesterol)	HDL-cholesterol (mg/dL)	baseline, 8 weeks
Change in leukocyte count	leukocyte count (/μL)	baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: ji won Lee, MD. PhD., 82-2-2019-3480

Publications and helpful links

General Publications

• Cho AR, Choi WJ, Kwon YJ, Lee HS, Ahn SG, Lee JW. Mediterranean Diet and Naltrexone/Bupropion Treatment for Weight Loss in Overweight and Obese Breast Cancer Survivors and Non-Cancer Participants: A Pilot Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2020 Sep 29;13:3325-3335. doi: 10.2147/DMSO.S269237. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 29, 2017
• Primary Completion (ACTUAL): July 22, 2018
• Study Completion (ACTUAL): July 22, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (ACTUAL): July 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Breast Neoplasms; Overweight; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Narcotic Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Alcohol Deterrents; Dopamine Uptake Inhibitors; Naltrexone; Bupropion
• Other Study ID Numbers: 3-2017-0097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No