Combined Nutrition and Exercise Interventions in Women With Breast Cancer History

NCT ID: NCT07275957

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Mediterranean Diet Counseling

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Supervised Strength Training Program

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Supervised Endurance Training Program

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Combined Strength and Endurance Training Program

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Combined Mediterranean Diet and Exercise Program

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alicante

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Alejandro Martínez-Rodríguez

Full Professor of Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

European Institute Of Exercise and Health

Elche, Alicante, Spain

Countries

Spain

Other Identifiers

UA-2025-06-13

Identifier Type: -

Identifier Source: org_study_id