Clinical trial · Interventional
Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients
Effects of Mediterranean Diet Based Intervention in Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: the Randomized Controlled Trial
NCT04045392CI-TRIAL-00039874unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this randomized clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation and metabolic risk factors in overweight or obese postmenopausal women with breast cancer receiving adjuvant hormone therapy.
Conditions
Conditions (2)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediterranean diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mediterranean diet group
- description
- Mediterranean diet with calorie restriction below 1,500 kcal per day.
- interventionNames
- Behavioral: Mediterranean diet
- type
- NO_INTERVENTION
- label
- Conventional diet group
- description
- Conventional diet with calorie restriction below 1,500 kcal per day.
Primary outcomes (4)
- measure
- Change in C-Reactive Protein (CRP) levels
- timeFrame
- Baseline, 8 weeks
- description
- Blood will be drawn from the participants for assessment of CRP levels (mg/L)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients who are receiving adjuvant hormone therapy after diagnosed with breast cancer stage Ⅰ-Ⅲ and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy * Postmenopausal women * Body mass index (BMI) ≥23 kg/m2 * 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 weight change more than 5kg in the previous 3 months * Participants with secondary causes of obesity, such as hypothyroidism * 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 serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation * Participants who are taking weight loss medications * Participants who are receiving systemic corticosteroid therapy * Participants with alcohol abuse or dependence * Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
References
Publications (1)
- DERIVEDCho AR, Hong KW, Kwon YJ, Choi JE, Lee HS, Kim HM, Bae SJ, Ahn SG, Jeong J, Lee JW. Effects of Single Nucleotide Polymorphisms and Mediterranean Diet in Overweight or Obese Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: A Pilot Randomized Controlled Trial. Front Nutr. 2022 Jul 1;9:882717. doi: 10.3389/fnut.2022.882717. eCollection 2022. PMID 35845810