Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients

Not Applicable

• Conditions: Breast Cancer; Obesity
• Interventions: Behavioral: Mediterranean diet

• Registration Number: NCT04045392
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-25
• Status Verified: 2019-08
• Study Start: 2019-08
• Study First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Study First Posted: 2019-08-05
• Last Update Posted: 2019-08-05
• Primary Completion: 2020-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean diet group	Mediterranean diet	Mediterranean diet with calorie restriction below 1,500 kcal per day.

Primary Outcome Measures

Name	Time	Method
Change in C-Reactive Protein (CRP) levels	Baseline, 8 weeks	Blood will be drawn from the participants for assessment of CRP levels (mg/L)
Change in fasting insulin levels	Baseline, 8 weeks	Blood will be drawn from the participants for assessment of fasting insulin levels (mcIU/mL) after fasting for at least 8 hours
Change in fasting glucose levels	Baseline, 8 weeks	Blood will be drawn from the participants for assessment of fasting glucose levels (mg/dL) after fasting for at least 8 hours
Change in lipid profile	Baseline, 8 weeks	Blood will be drawn from the participants for assessment of total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol (mg/dL) after fasting for at least 8 hours

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Baseline, 8 weeks	We will measure body weight (kg) of participants using the same scale
Change in fat mass measured by bioelectrical impedance analyzer	Baseline, 8 weeks	We will measure fat mass (kg) using bioelectrical impedance analyzer
Change in quality of life assessed by EORTC QLQ-C30 questionnaire	Baseline, 8 weeks	Quality of life will be assessed by questionnaire, named European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), score range 0\~100, higher scores indicate better quality of life
Change in quality of life assessed by OP scale questionnaire	Baseline, 8 weeks	Quality of life will be assessed by questionnaire, named Obesity-related problems scale (OP scale), scale range 0\~100, higher scores indicate more problems