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

NCT07443787 | Completed

• 1 other identifier: UOran1-2022-Nutrition-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Keywords

Dietary assessment; Mediterranean diet; Cardiovascular risk; Breast cancer survivors; physical activity; Endocrine therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in body mass index (BMI)

  Time Frame: Baseline and 3 months

• Change in lipid profile

  Baseline and 3 months

• Change in systolic and diastolic blood pressure

  Baseline and 3 months

Study Arms (1)

Lifestyle intervention group

OTHER

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; Behavioral: Physical activity promotion

Interventions

Mediterranean diet BEHAVIORAL

Dietary counseling and guidance to promote adherence to the Mediterranean diet over a 3-month period.

Lifestyle intervention group

Physical activity promotion BEHAVIORAL

Counseling and structured recommendations to increase regular physical activity over a 3-month period.

Lifestyle intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MOHAMEDI Ilhem Sarra Manel: lead
• University of Oran 1: collaborator

Study Sites (1)

Akid Othmane Hospital

Oran, Aïn-El-Turck, 31300, Algeria

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Behavior

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: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 2, 2026
• Study Start: May 2, 2022
• Primary Completion: February 26, 2025
• Study Completion: June 24, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AL (1)