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

Primary Purpose

Breast Cancer, Obesity, Overweight

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

naltrexone/bupropion

Mediterranean Diet

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

GangnamSeverance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet

Breast cancer subjects-Mediterranean Diet

Healthy subjects-naltrexone/bupropion+Mediterranean Diet

Arm Description

Outcomes

Primary Outcome Measures

Change in body weight

body weight (kg)

Change in fat mass

fat mass (kg) measured by bioelectrical impedance analyzer

Change in muscle mass

muscle mass (kg) measured by bioelectrical impedance analyzer

Change in fasting glucose

fasting glucose (mg/dL)

Change in insulin

insulin (mcIU/mL)

Change in triglyceride

triglyceride (mg/dL)

Change in high-density lipoprotein cholesterol (HDL-cholesterol)

HDL-cholesterol (mg/dL)

Change in leukocyte count

leukocyte count (/μL)

Secondary Outcome Measures

Full Information

NCT ID

NCT03581630

First Posted

May 15, 2018

Last Updated

August 28, 2018

Sponsor

Gangnam Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03581630

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 29, 2017 (Actual)

Primary Completion Date

July 22, 2018 (Actual)

Study Completion Date

July 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Obesity, Overweight

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet

Arm Type

Experimental

Arm Title

Breast cancer subjects-Mediterranean Diet

Arm Type

Experimental

Arm Title

Healthy subjects-naltrexone/bupropion+Mediterranean Diet

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

naltrexone/bupropion

Intervention Description

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

Behavioral

Intervention Name(s)

Mediterranean Diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in body weight

Description

body weight (kg)

Time Frame

baseline, 8 weeks

Title

Change in fat mass

Description

fat mass (kg) measured by bioelectrical impedance analyzer

Time Frame

baseline, 8 weeks

Title

Change in muscle mass

Description

muscle mass (kg) measured by bioelectrical impedance analyzer

Time Frame

baseline, 8 weeks

Title

Change in fasting glucose

Description

fasting glucose (mg/dL)

Time Frame

baseline, 8 weeks

Title

Change in insulin

Description

insulin (mcIU/mL)

Time Frame

baseline, 8 weeks

Title

Change in triglyceride

Description

triglyceride (mg/dL)

Time Frame

baseline, 8 weeks

Title

Change in high-density lipoprotein cholesterol (HDL-cholesterol)

Description

HDL-cholesterol (mg/dL)

Time Frame

baseline, 8 weeks

Title

Change in leukocyte count

Description

leukocyte count (/μL)

Time Frame

baseline, 8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ji won Lee, MD. PhD.

Organizational Affiliation

82-2-2019-3480

Official's Role

Principal Investigator

Facility Information:

Facility Name

GangnamSeverance Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

33061494

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.

Results Reference

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

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