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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581630
• Other study ID #: 3-2017-0097
• Status: Completed
• Phase: N/A
• Start date: July 29, 2017
• Est. completion date: July 22, 2018

Study information

• Verified date: August 2018
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 22, 2018
• Est. primary completion date: July 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Female, 20 to 65 years of age

• Diagnosed with breast cancer stage ?-?, 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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