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.

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.

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.