Breast Cancer, Obesity
Conditions
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.
Interventions
BEHAVIORALMediterranean diet
Two meals (breakfast and dinner) a day, five times a week, are delivered to participants' homes without charge. The meals are prepared, under the supervision of an expert nutritionist, by a chef trained on the principles of the Mediterranean diet.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed