Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients

Yonsei University Health System (YUHS)

Status

Unknown

Conditions

Breast Cancer

Obesity

Treatments

Behavioral: Mediterranean diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04045392

3-2019-0140

Details and patient eligibility

About

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.

Enrollment

78 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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