Combined Nutrition and Exercise Interventions in Women With Breast Cancer History

University of Alicante

Status: Active, not recruiting

Conditions: Breast Cancer Survivors

Treatments: Behavioral: Combined Strength and Endurance Training Program; Behavioral: Mediterranean Diet Counseling; Behavioral: Supervised Endurance Training Program; Behavioral: Combined Mediterranean Diet and Exercise Program; Behavioral: Supervised Strength Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07275957

UA-2025-06-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 6 patient groups

Arm 1 - Control Group

No Intervention group

Description:

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.

Arm 2 - Mediterranean Diet Group (MD)

Experimental group

Description:

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.

Treatment:

Behavioral: Mediterranean Diet Counseling

Arm 3 - Strength Training Group (ST)

Experimental group

Description:

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.

Treatment:

Behavioral: Supervised Strength Training Program

Arm 4 - Endurance Training Group (ET)

Experimental group

Description:

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.

Treatment:

Behavioral: Supervised Endurance Training Program

Arm 5 - Combined Training Group (CT)

Experimental group

Description:

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.

Treatment:

Behavioral: Combined Strength and Endurance Training Program

Arm 6 - Mediterranean Diet plus Combined Training Group (MD+CT)

Experimental group

Description:

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.

Treatment:

Behavioral: Combined Mediterranean Diet and Exercise Program