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Completed

NCT Number: NCT03581630

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

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.

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Key information

Conditions

Breast Cancer Body Weight Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone/Bupropion

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

Behavioral

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

Primary outcomes

  1. Change in body weight

    Time frame: baseline, 8 weeks

    body weight (kg)

  2. Change in fat mass

    Time frame: baseline, 8 weeks

    fat mass (kg) measured by bioelectrical impedance analyzer

  3. Change in muscle mass

    Time frame: baseline, 8 weeks

    muscle mass (kg) measured by bioelectrical impedance analyzer

  4. Change in fasting glucose

    Time frame: baseline, 8 weeks

    fasting glucose (mg/dL)

  5. Change in insulin

    Time frame: baseline, 8 weeks

    insulin (mcIU/mL)

  6. Change in triglyceride

    Time frame: baseline, 8 weeks

    triglyceride (mg/dL)

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

    Time frame: baseline, 8 weeks

    HDL-cholesterol (mg/dL)

  8. Change in leukocyte count

    Time frame: baseline, 8 weeks

    leukocyte count (/μL)

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2018
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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