Effects of Mediterranean Diet Based Intervention in Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: the Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Gangnam Severance Hospital
- Enrollment
- 78
- Primary Endpoint
- Change in C-Reactive Protein (CRP) levels
- Last Updated
- 6 years ago
Overview
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.
Investigators
Ji-Won Lee
Associate Professor, Department of Family Medicine
Gangnam Severance Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in C-Reactive Protein (CRP) levels
Time Frame: Baseline, 8 weeks
Blood will be drawn from the participants for assessment of CRP levels (mg/L)
Change in fasting insulin levels
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Change in body weight(Baseline, 8 weeks)
- Change in fat mass measured by bioelectrical impedance analyzer(Baseline, 8 weeks)
- Change in quality of life assessed by EORTC QLQ-C30 questionnaire(Baseline, 8 weeks)
- Change in quality of life assessed by OP scale questionnaire(Baseline, 8 weeks)