Breast CancerNCT03581630
Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
A study testing naltrexone/bupropion and Mediterranean Diet in people with Breast Cancer and Obesity, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Obesity, Overweight
- What is being tested?
- naltrexone/bupropion and Mediterranean Diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2017to 22 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- naltrexone/bupropion, Mediterranean Diet
- Medical subject headings
- Breast Neoplasms, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexone/bupropionDrug
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 DietBehavioural
Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet | Experimental | Not described Receives: Drug: naltrexone/bupropion; Behavioral: Mediterranean Diet |
| Breast cancer subjects-Mediterranean Diet | Experimental | Not described Receives: Behavioral: Mediterranean Diet |
| Healthy subjects-naltrexone/bupropion+Mediterranean Diet | Active comparator | Not described Receives: Drug: naltrexone/bupropion; Behavioral: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
body weight (kg)
Measured: baseline, 8 weeks
Change in fat mass
fat mass (kg) measured by bioelectrical impedance analyzer
Measured: baseline, 8 weeks
Change in muscle mass
muscle mass (kg) measured by bioelectrical impedance analyzer
Measured: baseline, 8 weeks
Change in fasting glucose
fasting glucose (mg/dL)
Measured: baseline, 8 weeks
Change in insulin
insulin (mcIU/mL)
Measured: baseline, 8 weeks
Change in triglyceride
triglyceride (mg/dL)
Measured: baseline, 8 weeks
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
HDL-cholesterol (mg/dL)
Measured: baseline, 8 weeks
Change in leukocyte count
leukocyte count (/μL)
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start29 Jul 2017
- Primary completion22 Jul 2018
- Study completion22 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Won Lee, Gangnam Severance Hospital
- Investigators
- ji won Lee, MD. PhD., Principal investigator, 82-2-2019-3480
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581630
- Sponsor's protocol ID
- 3-2017-0097
- Status last verified
- Aug 2018
- First submitted
- 15 May 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JH, Park JS, Park JJ, Lee JW, Chu SH, Lee HW, Yoon YR, Seong SJ, Gwon MR. Serum lipidomic profiles associated with Mediterranean diet in overweight and obese breast cancer survivors: an exploratory study. Eur J Nutr. 2026 Sep 19;65(7):256. doi: 10.1007/s00394-026-04108-2.
PubMed 42763329Cho 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.
PubMed 33061494
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03581630
- Acronym / sponsor ID
- 3-2017-0097
- Conditions
- Breast Cancer, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 29 Jul 2017 (actual)
- Primary completion
- 22 Jul 2018 (actual)
- Study completion
- 22 Jul 2018 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet | Experimental | Drug: naltrexone/bupropion, Behavioral: Mediterranean Diet |
| Breast cancer subjects-Mediterranean Diet | Experimental | Behavioral: Mediterranean Diet |
| Healthy subjects-naltrexone/bupropion+Mediterranean Diet | Active comparator | Drug: naltrexone/bupropion, Behavioral: Mediterranean Diet |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naltrexone/bupropionNaltrexone 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. | Drug | Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet, Healthy subjects-naltrexone/bupropion+Mediterranean Diet |
| Mediterranean DietDiet instruction and menu samples from the dietitian on following the Mediterranean Diet. | Behavioural | Breast cancer subjects-Mediterranean Diet, Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet, Healthy subjects-naltrexone/bupropion+Mediterranean Diet |
Primary outcome
Change in body weight
Time frame: baseline, 8 weeks
body weight (kg)
Change in fat mass
Time frame: baseline, 8 weeks
fat mass (kg) measured by bioelectrical impedance analyzer
Change in muscle mass
Time frame: baseline, 8 weeks
muscle mass (kg) measured by bioelectrical impedance analyzer
Change in fasting glucose
Time frame: baseline, 8 weeks
fasting glucose (mg/dL)
Change in insulin
Time frame: baseline, 8 weeks
insulin (mcIU/mL)
Change in triglyceride
Time frame: baseline, 8 weeks
triglyceride (mg/dL)
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
Time frame: baseline, 8 weeks
HDL-cholesterol (mg/dL)
Change in leukocyte count
Time frame: baseline, 8 weeks
leukocyte count (/μL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Derived from this study: PubMed 42763329Lee JH, Park JS, Park JJ, Lee JW, Chu SH, Lee HW, Yoon YR, Seong SJ, Gwon MR. Serum lipidomic profiles associated with Mediterranean diet in overweight and obese breast cancer survivors: an exploratory study. Eur J Nutr. 2026 Sep 19;65(7):256. doi: 10.1007/s00394-026-04108-2.
- Derived from this study: PubMed 33061494Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ji won Lee, MD. PhD. principal investigator
82-2-2019-3480
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing naltrexone/bupropion and Mediterranean Diet in people with Breast Cancer and Obesity, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: baseline, 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03581630, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.