Mediterranean Diet and Physical Activity in Breast Cancer Patients Under Hormone Therapy

Impact of a Mediterranean-type Diet and Promotion of Physical Activity on Nutritional Status and Cardiometabolic Risk in Breast Cancer Patients Undergoing Adjuvant Hormone Therapy

This study aims to evaluate body weight status, lifestyle patterns, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the effects of a structured nutritional intervention based on the Mediterranean diet combined with physical activity promotion.

A total of 150 women treated with adjuvant hormone therapy are recruited from the oncology department of Akid Othmane Hospital in Oran, Algeria. Participants include women receiving tamoxifen or aromatase inhibitors. Baseline assessments include anthropometric measurements (body weight, body mass index, waist and hip circumferences), socioeconomic characteristics, and lifestyle evaluation.

Dietary intake is assessed using 24-hour dietary recalls and 3-day food records. Total energy intake, macronutrient and micronutrient composition, dietary habits, meal distribution, and adherence to the Mediterranean diet (MEDAS score) are evaluated. Physical activity level, sedentary behavior, daily energy expenditure, and energy balance are also determined.

Cardiometabolic risk is assessed through measurement of blood pressure, fasting blood glucose, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), uric acid, albumin, creatinine, urea, and calculation of atherogenic ratios.

A structured educational program promoting adherence to the Mediterranean diet and increased physical activity is implemented. Anthropometric, dietary, lifestyle, and cardiometabolic parameters are monitored over time to evaluate changes associated with the intervention.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Mediterranean diet; Behavioral: Physical activity promotion

Detailed Description

The objective of this interventional study is to evaluate body weight status, lifestyle characteristics, and cardiometabolic risk in women in remission from breast cancer undergoing adjuvant hormone therapy, and to assess the impact of a nutritional intervention based on the Mediterranean diet combined with physical activity promotion.

A total of 150 women treated with adjuvant hormone therapy are recruited from the oncology department of Akid Othmane Hospital in Aïn El Turc, Oran, Algeria. Participants are classified according to the type of endocrine treatment received, including tamoxifen or aromatase inhibitors.

Baseline evaluation includes anthropometric measurements such as body weight, body mass index, waist circumference, and hip circumference. Socioeconomic characteristics and lifestyle habits are documented.

Dietary assessment is conducted using 24-hour dietary recalls and 3-day food records. Nutritional analysis includes total energy intake, macronutrient and micronutrient composition, dietary quality, meal distribution, and adherence to the Mediterranean diet assessed using the MEDAS score. Food group consumption patterns and dietary behaviors are also evaluated.

Physical activity level, sedentary behavior, daily energy expenditure, and energy balance are determined using standardized assessment methods.

Cardiometabolic risk profile is evaluated through measurement of blood pressure, fasting blood glucose, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), uric acid, albumin, creatinine, urea, and calculation of atherogenic indices.

Following baseline assessment, participants receive a structured educational program promoting adherence to the Mediterranean dietary pattern and regular physical activity. Follow-up assessments are conducted to monitor changes in anthropometric parameters, dietary habits, lifestyle behaviors, and cardiometabolic markers over time.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Algeria
  • Aïn-El-Turck
    • Oran, Aïn-El-Turck, Algeria, 31300
      • Akid Othmane Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed hormone receptor-positive breast cancer
• Breast cancer survivors receiving adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) for ≥3 months
• No recurrence or second primary malignancy
• Ability to perform moderate-intensity physical activity
• Consecutively recruited during routine surveillance visits

Exclusion Criteria:

• Incomplete or discontinued hormone therapy
• Concurrent ovarian suppression
• Use of lipid-lowering medications
• Severe uncontrolled comorbidities (e.g., diabetes, cardiac, or hepatic disease)
• Cognitive or physical impairments preventing informed consent or participation
• Restrictive dietary regimens

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lifestyle intervention group; Breast cancer patients receiving a Mediterranean diet intervention combined with physical activity promotion for 3 months, with assessments conducted at baseline and after the intervention.	Behavioral: Mediterranean diet; Dietary counseling and guidance to promote adherence to the Mediterranean diet over a 3-month period.; Behavioral: Physical activity promotion; Counseling and structured recommendations to increase regular physical activity over a 3-month period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in waist circumference	Change in waist circumference measured in centimeters between baseline and after 3 months of lifestyle intervention.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass index (BMI)		Time Frame: Baseline and 3 months
Change in lipid profile	Description: Changes in total cholesterol, LDL-C, HDL-C and triglycerides	Baseline and 3 months
Change in systolic and diastolic blood pressure		Baseline and 3 months

Collaborators and Investigators

• Sponsor: MOHAMEDI Ilhem Sarra Manel
• Collaborators: University of Oran 1

Publications and helpful links

General Publications

• Mohamedi ISM, Ghomari-Boukhatem H, Moussaoui I, Raiah M, Bouchenak M. Lifestyle factors and cardiometabolic risk in breast cancer patients under different hormones therapy. Med J Nutrition Metab. 2025; 18(3):194-203. doi:10.1177/1973798X251353349.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): June 24, 2025

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; Breast cancer survivors; Cardiovascular risk; Mediterranean diet; Dietary assessment; Endocrine therapy
• Additional Relevant MeSH Terms: Behavior; Cardiovascular Diseases; Motor Activity; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Mediterranean
• Other Study ID Numbers: UOran1-2022-Nutrition-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Only aggregated results, such as means and standard deviations of measured outcomes, will be published to evaluate the impact of the Mediterranean diet and physical activity promotion. All data will remain confidential and no personal identifiers will be made publicly available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No