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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
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

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

    First Posted
    July 25, 2019
    Last Updated
    August 2, 2019
    Sponsor
    Gangnam Severance Hospital
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    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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