Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediterranean diet | Behavioral | — | UNRESOLVED |
| Physical activity promotion | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Lifestyle intervention group
- description
- 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.
- interventionNames
- Behavioral: Mediterranean diet
- Behavioral: Physical activity promotion
Primary outcomes (1)
- measure
- Change in waist circumference
- timeFrame
- Baseline and 3 months
- description
- Change in waist circumference measured in centimeters between baseline and after 3 months of lifestyle intervention.
Secondary outcomes (3)
- measure
- Change in body mass index (BMI)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDMohamedi 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.