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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03581630
Other study ID # 3-2017-0097
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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