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

NCT ID: NCT03581630

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-29
• Study Completion Date: 2018-07-22

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.

Conditions

Breast Cancer; Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet

Group Type: EXPERIMENTAL

naltrexone/bupropion

Intervention Type: DRUG

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.

Mediterranean Diet

Intervention Type: BEHAVIORAL

Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.

Breast cancer subjects-Mediterranean Diet

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: BEHAVIORAL

Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.

Healthy subjects-naltrexone/bupropion+Mediterranean Diet

Group Type: ACTIVE_COMPARATOR

naltrexone/bupropion

Intervention Type: DRUG

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.

Mediterranean Diet

Intervention Type: BEHAVIORAL

Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.

Interventions

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.

Intervention Type: DRUG

Mediterranean Diet

Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji-Won Lee

Associate Professor (Department of Family Medicine, Gangnam Severance Hospital,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ji won Lee, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

82-2-2019-3480

Locations

GangnamSeverance Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 33061494 (View on PubMed)

Other Identifiers

3-2017-0097

Identifier Type: -

Identifier Source: org_study_id