Clinical trial NCT03581630: Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
Official title: Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment on Body Weight and Metabolic Risk Factors in Obese Breast Cancer Patients After Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Obesity
Overweight
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 72
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Change in body weight
timeFrame: baseline, 8 weeks
measure: Change in fat mass
timeFrame: baseline, 8 weeks
measure: Change in muscle mass
timeFrame: baseline, 8 weeks
measure: Change in fasting glucose
timeFrame: baseline, 8 weeks
measure: Change in insulin
timeFrame: baseline, 8 weeks
measure: Change in triglyceride
timeFrame: baseline, 8 weeks
measure: Change in high-density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: baseline, 8 weeks
measure: Change in leukocyte count
timeFrame: baseline, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
affiliation: 82-2-2019-3480
name: ji won Lee, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.