Effects of Mediterranean Diet Based Intervention in Breast Cancer Patients

NCT04045392 | Unknown

• 1 other identifier: 3-2019-0140
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Obesity

Outcome Measures

Primary Outcomes (4)

• Change in C-Reactive Protein (CRP) levels

  Blood will be drawn from the participants for assessment of CRP levels (mg/L)

  Baseline, 8 weeks

• 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

• 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

• 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 Outcomes (4)

• Change in body weight

  Baseline, 8 weeks

• Change in fat mass measured by bioelectrical impedance analyzer

  Baseline, 8 weeks

• Change in quality of life assessed by EORTC QLQ-C30 questionnaire

  Baseline, 8 weeks

• Change in quality of life assessed by OP scale questionnaire

  Baseline, 8 weeks

Study Arms (2)

Mediterranean diet group

EXPERIMENTAL

Mediterranean diet with calorie restriction below 1,500 kcal per day.

Behavioral: Mediterranean diet

Conventional diet group

NO INTERVENTION

Conventional diet with calorie restriction below 1,500 kcal per day.

Interventions

Mediterranean diet BEHAVIORAL

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.

Mediterranean diet group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Related Publications (1)

• 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.

  PMID: 35845810 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Family Medicine

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 5, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: August 5, 2019

Record last verified: 2019-08