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NCT Number: NCT07275957

Combined Nutrition and Exercise Interventions in Women With Breast Cancer History

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Survivors

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

European Institute Of Exercise and Health

Elche, Alicante, 03203, Spain

About this study

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:

  • Control group - no intervention.
  • Mediterranean diet group (MD) - individualized nutritional plan based on Mediterranean dietary patterns.
  • Strength training group (ST) - supervised resistance exercise sessions.
  • Endurance training group (ET) - supervised aerobic exercise sessions.
  • Combined training group (CT) - combination of strength and endurance training.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Mediterranean diet counseling

Behavioral

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.

Supervised Strength Training Program

Behavioral

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.

Supervised Endurance Training Program

Behavioral

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.

Combined Strength and Endurance Training Program

Behavioral

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.

Combined Mediterranean Diet and Exercise Program

Behavioral

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.

Primary outcomes

  1. Change in Fat-Free Mass (kg)

    Time frame: Baseline and Week 12

    To evaluate changes in fat-free mass after the 12-week intervention, measured by bioimpedance analysis (BIODY XPERT ZM).

Secondary outcomes

  1. Change in Fat Mass (%)

    Time frame: Baseline and Week 12

    To assess changes in total body fat percentage using bioimpedance analysis.

  2. Change in Body Weight (kg)

    Time frame: Baseline and Week 12

    To determine body weight variation during the 12-week intervention.

  3. Change in Body Mass Index (kg/m²)

    Time frame: Baseline and Week 12

    To evaluate changes in BMI calculated as weight divided by height squared.

  4. Change in Waist Circumference (cm)

    Time frame: Baseline and Week 12

    To assess central adiposity changes by measuring waist circumference.

  5. Change in Handgrip Strength (kg)

    Time frame: Baseline and Week 12

    To evaluate upper-body muscular strength using a digital hand dynamometer.

  6. Change in Lower-Limb Strength (kg)

    Time frame: Baseline and Week 12

    To assess lower-limb strength through isometric tests using a load cell or force platform.

  7. Change in Functional Capacity (6-Minute Walk Test Distance, m)

    Time frame: Baseline and Week 12

    To evaluate cardiorespiratory endurance using the 6-minute walk test.

  8. Change in Balance Performance

    Time frame: Baseline and Week 12

    To assess dynamic balance and postural control

  9. Change in Flexibility (Sit-and-Reach Test, cm)

    Time frame: Baseline and Week 12

    To evaluate flexibility of the posterior chain through the sit-and-reach test.

  10. Change in Maximal Oxygen Uptake (VO₂max, mL/kg/min)

    Time frame: Baseline and Week 12

    To determine changes in aerobic capacity using an incremental treadmill test with indirect calorimetry (METALYZ-ERR 3 B-R3 spirometer).

  11. Change in Total Cholesterol (mg/dL)

    Time frame: Baseline and Week 12

    To evaluate lipid profile variations by measuring total cholesterol concentration.

  12. Change in HDL Cholesterol (mg/dL)

    Time frame: Baseline and Week 12

    To assess cardioprotective lipid changes.

  13. Change in LDL Cholesterol (mg/dL)

    Time frame: Baseline and Week 12

    To measure changes in LDL cholesterol levels.

  14. Change in Triglycerides (mg/dL)

    Time frame: Baseline and Week 12

    To determine variations in triglyceride concentration.

  15. Change in Fasting Glucose (mg/dL)

    Time frame: Baseline and Week 12

    To assess metabolic health by measuring fasting plasma glucose.

  16. Change in C-Reactive Protein (mg/L)

    Time frame: Baseline and Week 12

    To evaluate systemic inflammation using CRP levels.

  17. Change in Interleukin-6 (pg/mL)

    Time frame: Baseline and Week 12

    To measure inflammatory status via IL-6 concentration.

  18. Change in Fatigue (FACIT-F Questionnaire Score)

    Time frame: Baseline and Week 12

    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.

  19. Change in Sleep Quality (PSQI Total Score)

    Time frame: Baseline and Week 12

    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.

  20. Change in Physical Activity Level (IPAQ Total Score)

    Time frame: Baseline and Week 12

    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.

  21. Change in Dietary Adherence (Mediterranean Diet Adherence Screener Score)

    Time frame: Baseline and Week 12

    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.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Feb 4, 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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