Combined Nutrition and Exercise Interventions in Women With Breast Cancer History

Study of the Effects of Implementing Dietary-nutritional Strategies and an Exercise Program at the Physical, Physiological, and Psychological Level in Women With a History of Breast Cancer.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer Survivors
• Intervention / Treatment: Behavioral: Mediterranean Diet Counseling; Behavioral: Supervised Strength Training Program; Behavioral: Supervised Endurance Training Program; Behavioral: Combined Strength and Endurance Training Program; Behavioral: Combined Mediterranean Diet and Exercise Program

Detailed Description

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:

1. Control group - no intervention.
2. Mediterranean diet group (MD) - individualized nutritional plan based on Mediterranean dietary patterns.
3. Strength training group (ST) - supervised resistance exercise sessions.
4. Endurance training group (ET) - supervised aerobic exercise sessions.
5. Combined training group (CT) - combination of strength and endurance training.
6. Combined diet and exercise group (MD+CT) - simultaneous application of Mediterranean diet and combined training.

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03203
      • European Institute Of Exercise and Health

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Women aged 30 to 65 years.
• Previous diagnosis of breast cancer (stages I-III) confirmed by medical records.
• Completion of primary oncological treatment (surgery, radiotherapy, chemotherapy, and/or hormone therapy) at least 3 months before enrollment.
• Absence of active cancer or evidence of recurrence.
• Medical clearance to perform physical exercise.
• Willingness to participate in dietary and/or exercise interventions for 12 weeks.
• Ability to attend evaluation and intervention sessions and comply with study procedures.
• Signed written informed consent.

Exclusion Criteria:

• Active cancer, metastasis, or ongoing chemotherapy or radiotherapy.
• Severe cardiovascular, respiratory, renal, hepatic, or metabolic disease that contraindicates exercise.
• Musculoskeletal or neurological conditions limiting participation in physical activity.
• Severe psychiatric disorders or cognitive impairment affecting adherence to the intervention.
• Current participation in another clinical trial or structured lifestyle intervention.
• Use of dietary supplements, appetite regulators, or pharmacological agents affecting metabolism during the study period.
• Pregnancy, breastfeeding, or intention to become pregnant during the study.
• Inability to comply with the intervention schedule or follow-up assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1 - Control Group; 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.
Experimental: Arm 2 - Mediterranean Diet Group (MD); 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; 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.
Experimental: Arm 3 - Strength Training Group (ST); 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; 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.
Experimental: Arm 4 - Endurance Training Group (ET); 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; 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.
Experimental: Arm 5 - Combined Training Group (CT); 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; 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.
Experimental: Arm 6 - Mediterranean Diet plus Combined Training Group (MD+CT); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fat Mass (%)	To assess changes in total body fat percentage using bioimpedance analysis.	Baseline and Week 12
Change in Body Weight (kg)	To determine body weight variation during the 12-week intervention.	Baseline and Week 12
Change in Body Mass Index (kg/m²)	To evaluate changes in BMI calculated as weight divided by height squared.	Baseline and Week 12
Change in Waist Circumference (cm)	To assess central adiposity changes by measuring waist circumference.	Baseline and Week 12
Change in Handgrip Strength (kg)	To evaluate upper-body muscular strength using a digital hand dynamometer.	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.	Baseline and Week 12
Change in Functional Capacity (6-Minute Walk Test Distance, m)	To evaluate cardiorespiratory endurance using the 6-minute walk test.	Baseline and Week 12
Change in Balance Performance	To assess dynamic balance and postural control	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.	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).	Baseline and Week 12
Change in Total Cholesterol (mg/dL)	To evaluate lipid profile variations by measuring total cholesterol concentration.	Baseline and Week 12
Change in HDL Cholesterol (mg/dL)	To assess cardioprotective lipid changes.	Baseline and Week 12
Change in LDL Cholesterol (mg/dL)	To measure changes in LDL cholesterol levels.	Baseline and Week 12
Change in Triglycerides (mg/dL)	To determine variations in triglyceride concentration.	Baseline and Week 12
Change in Fasting Glucose (mg/dL)	To assess metabolic health by measuring fasting plasma glucose.	Baseline and Week 12
Change in C-Reactive Protein (mg/L)	To evaluate systemic inflammation using CRP levels.	Baseline and Week 12
Change in Interleukin-6 (pg/mL)	To measure inflammatory status via IL-6 concentration.	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.	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.	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.	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.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: University of Alicante

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Aerobic exercise; Quality of life; Breast cancer survivors; Body composition; Lifestyle modification; Strength training; Mediterranean diet; Nutritional intervention; Exercise intervention; Physical rehabilitation; Combined training
• Other Study ID Numbers: UA-2025-06-13

Drug and device information, study documents

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