Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients
Primary Purpose
Breast Cancer, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mediterranean diet
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mediterranean diet group
Conventional diet group
Arm Description
Mediterranean diet with calorie restriction below 1,500 kcal per day.
Conventional diet with calorie restriction below 1,500 kcal per day.
Outcomes
Primary Outcome Measures
Change in C-Reactive Protein (CRP) levels
Blood will be drawn from the participants for assessment of CRP levels (mg/L)
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
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
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
Secondary Outcome Measures
Change in body weight
We will measure body weight (kg) of participants using the same scale
Change in fat mass measured by bioelectrical impedance analyzer
We will measure fat mass (kg) using bioelectrical impedance analyzer
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
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
Full Information
NCT ID
NCT04045392
First Posted
July 25, 2019
Last Updated
August 2, 2019
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04045392
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mediterranean diet group
Arm Type
Experimental
Arm Description
Mediterranean diet with calorie restriction below 1,500 kcal per day.
Arm Title
Conventional diet group
Arm Type
No Intervention
Arm Description
Conventional diet with calorie restriction below 1,500 kcal per day.
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in C-Reactive Protein (CRP) levels
Description
Blood will be drawn from the participants for assessment of CRP levels (mg/L)
Time Frame
Baseline, 8 weeks
Title
Change in fasting insulin levels
Description
Blood will be drawn from the participants for assessment of fasting insulin levels (mcIU/mL) after fasting for at least 8 hours
Time Frame
Baseline, 8 weeks
Title
Change in fasting glucose levels
Description
Blood will be drawn from the participants for assessment of fasting glucose levels (mg/dL) after fasting for at least 8 hours
Time Frame
Baseline, 8 weeks
Title
Change in lipid profile
Description
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
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in body weight
Description
We will measure body weight (kg) of participants using the same scale
Time Frame
Baseline, 8 weeks
Title
Change in fat mass measured by bioelectrical impedance analyzer
Description
We will measure fat mass (kg) using bioelectrical impedance analyzer
Time Frame
Baseline, 8 weeks
Title
Change in quality of life assessed by EORTC QLQ-C30 questionnaire
Description
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
Time Frame
Baseline, 8 weeks
Title
Change in quality of life assessed by OP scale questionnaire
Description
Quality of life will be assessed by questionnaire, named Obesity-related problems scale (OP scale), scale range 0~100, higher scores indicate more problems
Time Frame
Baseline, 8 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
35845810
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.
Results Reference
derived
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Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients
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