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Completed

NCT Number: NCT07443787

Mediterranean Diet and Physical Activity in Breast Cancer Patients Under 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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Akid Othmane Hospital

Oran, Aïn-El-Turck, 31300, Algeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet

Behavioral

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

Physical Activity Promotion

Behavioral

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

Primary outcomes

  1. Change in waist circumference

    Time frame: Baseline and 3 months

    Change in waist circumference measured in centimeters between baseline and after 3 months of lifestyle intervention.

Secondary outcomes

  1. Change in body mass index (BMI)

    Time frame: Time Frame: Baseline and 3 months

  2. Change in lipid profile

    Time frame: Baseline and 3 months

    Description: Changes in total cholesterol, LDL-C, HDL-C and triglycerides

  3. Change in systolic and diastolic blood pressure

    Time frame: Baseline and 3 months

Sponsors and collaborators

Lead sponsor

MOHAMEDI Ilhem Sarra Manel

Other

Collaborators

  • University of Oran 1

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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