Clinical trial NCT04045392: Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients
Official title: Effects of Mediterranean Diet Based Intervention in Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: the Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Obesity
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 78
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in C-Reactive Protein (CRP) levels
timeFrame: Baseline, 8 weeks
measure: Change in fasting insulin levels
timeFrame: Baseline, 8 weeks
measure: Change in fasting glucose levels
timeFrame: Baseline, 8 weeks
measure: Change in lipid profile
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline, 8 weeks
measure: Change in fat mass measured by bioelectrical impedance analyzer
timeFrame: Baseline, 8 weeks
measure: Change in quality of life assessed by EORTC QLQ-C30 questionnaire
timeFrame: Baseline, 8 weeks
measure: Change in quality of life assessed by OP scale questionnaire
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Cho 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.