An interventional study of Mediterranean Diet Counseling and Supervised Strength Training Program in Breast Cancer Survivors, sponsored by University of Alicante. Completed at 1 site in Spain. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University of Alicante · Not applicable, Interventional, and Treatment
This study aims to evaluate the effects of a combined dietary-nutritional and physical exercise intervention on physical, physiological, and psychological outcomes in women who are breast cancer survivors. Participants will be randomly assigned to different intervention groups involving dietary modification, exercise training, or their combination, compared to a control group. The program will last 12 weeks and will include pre- and post-intervention assessments of body composition, metabolic parameters, functional capacity, and quality of life.
The primary goal is to assess improvements in physical fitness, body composition, and emotional well-being, as well as to identify potential synergistic effects of combined interventions in this population.
Breast cancer survivors often experience long-term physical and psychological side effects derived from treatment, such as fatigue, loss of muscle mass, metabolic alterations, and reduced quality of life. Lifestyle interventions involving nutrition and exercise have demonstrated significant potential to mitigate these effects and promote overall recovery.
This randomized controlled clinical trial will include adult female breast cancer survivors who have completed their primary oncological treatment. Participants will be divided into six parallel groups:
The intervention will last 12 weeks, during which participants in the intervention groups will attend supervised sessions and receive continuous nutritional guidance. Assessments will be performed at baseline and after 12 weeks, including anthropometric and body composition analysis, metabolic and inflammatory markers, physical fitness testing, dietary intake, and psychological well-being scales.
This study seeks to identify the most effective strategy-dietary, physical, or combined-for improving health outcomes, functionality, and emotional recovery in breast cancer survivors, contributing to the development of comprehensive post-treatment rehabilitation programs.
University of Alicante is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will not receive any specific dietary or exercise intervention. They will be asked to maintain their usual lifestyle and dietary habits during the 12-week study period. General health recommendations based on national guidelines will be provided at baseline.
Participants will receive individualized nutritional counseling promoting adherence to a Mediterranean dietary pattern, emphasizing fruits, vegetables, legumes, whole grains, olive oil, nuts, fish, and moderate dairy intake. Processed and high-sugar foods will be limited. Dietitians will provide personalized follow-up and adjustments every two weeks to ensure adherence.
Behavioral: Mediterranean Diet Counseling
Participants will perform a 12-week supervised resistance training program focused on improving muscular strength and functional capacity. Sessions will be conducted three times per week, lasting approximately 60 minutes, and include major muscle groups using elastic bands, free weights, and bodyweight exercises. Training load will progressively increase according to individual capacity.
Behavioral: Supervised Strength Training Program
Participants will follow a structured aerobic exercise program consisting of walking, cycling, or treadmill sessions three times per week for 12 weeks. The intensity will be moderate (60-75% of estimated maximal heart rate), gradually progressing as tolerated. The goal is to enhance cardiorespiratory fitness and overall endurance.
Behavioral: Supervised Endurance Training Program
Participants will perform both strength and aerobic training during the 12-week intervention. Each session (3 per week, 60-70 minutes) will include resistance exercises targeting major muscle groups followed by aerobic activity at moderate intensity. The program aims to improve both muscular and cardiovascular performance synergistically.
Behavioral: Combined Strength and Endurance Training Program
Participants will simultaneously receive the Mediterranean Diet counseling and participate in the Combined Training program for 12 weeks. The objective is to assess the synergistic effects of diet and exercise on physical, physiological, and psychological health in breast cancer survivors.
Behavioral: Combined Mediterranean Diet and Exercise Program
Individualized nutritional counseling based on Mediterranean diet principles, emphasizing the intake of fruits, vegetables, legumes, whole grains, nuts, olive oil, and fish, while reducing red meat, processed foods, and added sugars. Sessions will be held biweekly to ensure adherence and promote long-term dietary behavior change.
A structured resistance exercise program performed three times per week for 12 weeks. Each 60-minute session will include exercises for major muscle groups using elastic bands, dumbbells, or body weight, progressively increasing intensity to improve muscle strength and endurance.
A structured aerobic exercise program consisting of walking, cycling, or treadmill training three times per week for 12 weeks. Exercise intensity will range from 60% to 75% of the estimated maximal heart rate, progressively adjusted to enhance cardiovascular fitness and fatigue resistance.
A combined exercise protocol including both resistance and aerobic components within each 60-70-minute session, three times per week for 12 weeks. Strength exercises will precede moderate-intensity aerobic work to improve overall physical performance and functional capacity.
Comprehensive lifestyle intervention combining Mediterranean diet counseling with the supervised combined training program. Participants will receive individualized diet plans and attend three supervised exercise sessions per week. The intervention targets improvements in body composition, physical fitness, and emotional well-being.
Change in Fat-Free Mass (kg)
To evaluate changes in fat-free mass after the 12-week intervention, measured by bioimpedance analysis (BIODY XPERT ZM).
Time frame: Baseline and Week 12
Change in Fat Mass (%)
To assess changes in total body fat percentage using bioimpedance analysis.
Time frame: Baseline and Week 12
Change in Body Weight (kg)
To determine body weight variation during the 12-week intervention.
Time frame: Baseline and Week 12
Change in Body Mass Index (kg/m²)
To evaluate changes in BMI calculated as weight divided by height squared.
Time frame: Baseline and Week 12
Change in Waist Circumference (cm)
To assess central adiposity changes by measuring waist circumference.
Time frame: Baseline and Week 12
Change in Handgrip Strength (kg)
To evaluate upper-body muscular strength using a digital hand dynamometer.
Time frame: Baseline and Week 12
Change in Lower-Limb Strength (kg)
To assess lower-limb strength through isometric tests using a load cell or force platform.
Time frame: Baseline and Week 12
Change in Functional Capacity (6-Minute Walk Test Distance, m)
To evaluate cardiorespiratory endurance using the 6-minute walk test.
Time frame: Baseline and Week 12
Change in Balance Performance
To assess dynamic balance and postural control
Time frame: Baseline and Week 12
Change in Flexibility (Sit-and-Reach Test, cm)
To evaluate flexibility of the posterior chain through the sit-and-reach test.
Time frame: Baseline and Week 12
Change in Maximal Oxygen Uptake (VO₂max, mL/kg/min)
To determine changes in aerobic capacity using an incremental treadmill test with indirect calorimetry (METALYZ-ERR 3 B-R3 spirometer).
Time frame: Baseline and Week 12
Change in Total Cholesterol (mg/dL)
To evaluate lipid profile variations by measuring total cholesterol concentration.
Time frame: Baseline and Week 12
Change in HDL Cholesterol (mg/dL)
To assess cardioprotective lipid changes.
Time frame: Baseline and Week 12
Change in LDL Cholesterol (mg/dL)
To measure changes in LDL cholesterol levels.
Time frame: Baseline and Week 12
Change in Triglycerides (mg/dL)
To determine variations in triglyceride concentration.
Time frame: Baseline and Week 12
Change in Fasting Glucose (mg/dL)
To assess metabolic health by measuring fasting plasma glucose.
Time frame: Baseline and Week 12
Change in C-Reactive Protein (mg/L)
To evaluate systemic inflammation using CRP levels.
Time frame: Baseline and Week 12
Change in Interleukin-6 (pg/mL)
To measure inflammatory status via IL-6 concentration.
Time frame: Baseline and Week 12
Change in Fatigue (FACIT-F Questionnaire Score)
Description: Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F). This questionnaire consists of 13 items rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very much"), reflecting fatigue experienced during the past 7 days. The total score is calculated by summing the item scores (after reverse scoring where applicable). Range: 0-52. Interpretation: Higher scores indicate less fatigue and therefore a better functional status, while lower scores reflect greater fatigue severity.
Time frame: Baseline and Week 12
Change in Sleep Quality (PSQI Total Score)
Description: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-reported questionnaire that evaluates sleep quality and disturbances over the previous month. The items are grouped into seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), each scored from 0 to 3. The global PSQI score is the sum of the components (range 0-21). Range: 0-21. Interpretation: Higher scores indicate poorer sleep quality.
Time frame: Baseline and Week 12
Change in Physical Activity Level (IPAQ Total Score)
Description: Physical activity levels will be evaluated using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), which records the frequency and duration of walking, moderate, and vigorous activities over the past 7 days. The results are expressed as total metabolic equivalent minutes per week (MET-min/week) and can be categorized into three levels: low, moderate, or high activity. Range: 0 to unlimited MET-min/week. Interpretation: Higher scores indicate higher physical activity levels.
Time frame: Baseline and Week 12
Change in Dietary Adherence (Mediterranean Diet Adherence Screener Score)
Description: Adherence to the Mediterranean diet will be assessed using the PREDIMED Questionnaire, a validated 14-item questionnaire evaluating key dietary habits such as olive oil use, fruit and vegetable consumption, fish intake, and limitation of red meat and sweets. Each affirmative answer scores 1 point, yielding a total score from 0 (minimal adherence) to 14 (maximal adherence). Range: 0-14. Interpretation: Higher scores indicate better adherence to the Mediterranean dietary pattern.
Time frame: Baseline and Week 12
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Alicante