Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Effects of Mediterranean Diet Based Intervention in Postmenopausal Women With Breast Cancer Receiving Adjuvant Hormone Therapy: the Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04045392
• Other study ID #: 3-2019-0140
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: August 2021

Study information

• Verified date: August 2019
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: August 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Breast cancer patients who are receiving adjuvant hormone therapy after diagnosed with breast cancer stage ?-? 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity

Intervention

Behavioral:
• Mediterranean 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in C-Reactive Protein (CRP) levels	Blood will be drawn from the participants for assessment of CRP levels (mg/L)	Baseline, 8 weeks
Primary	Change in fasting insulin levels	Blood will be drawn from the participants for assessment of fasting insulin levels (mcIU/mL) after fasting for at least 8 hours	Baseline, 8 weeks
Primary	Change in fasting glucose levels	Blood will be drawn from the participants for assessment of fasting glucose levels (mg/dL) after fasting for at least 8 hours	Baseline, 8 weeks
Primary	Change in lipid profile	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	Baseline, 8 weeks
Secondary	Change in body weight	We will measure body weight (kg) of participants using the same scale	Baseline, 8 weeks
Secondary	Change in fat mass measured by bioelectrical impedance analyzer	We will measure fat mass (kg) using bioelectrical impedance analyzer	Baseline, 8 weeks
Secondary	Change in quality of life assessed by EORTC QLQ-C30 questionnaire	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	Baseline, 8 weeks
Secondary	Change in quality of life assessed by OP scale questionnaire	Quality of life will be assessed by questionnaire, named Obesity-related problems scale (OP scale), scale range 0~100, higher scores indicate more problems	Baseline, 8 weeks