Clinical trial · Interventional
Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment on Body Weight and Metabolic Risk Factors in Obese Breast Cancer Patients After Breast Cancer Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediterranean Diet | Behavioral | — | UNRESOLVED |
| naltrexone/bupropion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Breast cancer subjects-naltrexone/bupropion+Mediterranean Diet
- interventionNames
- Drug: naltrexone/bupropion
- Behavioral: Mediterranean Diet
- type
- EXPERIMENTAL
- label
- Breast cancer subjects-Mediterranean Diet
- interventionNames
- Behavioral: Mediterranean Diet
- type
- ACTIVE_COMPARATOR
- label
- Healthy subjects-naltrexone/bupropion+Mediterranean Diet
- interventionNames
- Drug: naltrexone/bupropion
- Behavioral: Mediterranean Diet
Primary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCho 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. PMID 33061494