NCT07275957

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Alicante · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Cancer Survivors

Interventions

Type	Name	Description
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.
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.
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.
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.
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2025-12-10
• Last updated: 2026-02-04

Locations

1 site across 1 country: Spain