Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jul 2017
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2017
CompletedFirst Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2018
CompletedAugust 29, 2018
August 1, 2018
12 months
May 15, 2018
August 28, 2018
Conditions
Outcome Measures
Primary Outcomes (8)
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
Study Arms (3)
Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet
EXPERIMENTALBreast cancer subjects-Mediterranean Diet
EXPERIMENTALHealthy subjects-naltrexone/bupropion+Mediterranean Diet
ACTIVE COMPARATORInterventions
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.
Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GangnamSeverance Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 33061494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ji won Lee, MD. PhD.
82-2-2019-3480
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor (Department of Family Medicine, Gangnam Severance Hospital,
Study Record Dates
First Submitted
May 15, 2018
First Posted
July 10, 2018
Study Start
July 29, 2017
Primary Completion
July 22, 2018
Study Completion
July 22, 2018
Last Updated
August 29, 2018
Record last verified: 2018-08