Combined Nutrition and Exercise Interventions in Women With Breast Cancer History

NCT07275957 | Active Not Recruiting

• 1 other identifier: UA-2025-06-13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivors

Keywords

Breast cancer survivors; Exercise intervention; Nutritional intervention; Mediterranean diet; Physical rehabilitation; Quality of life; Body composition; Strength training; Aerobic exercise; Combined training; Lifestyle modification

Outcome Measures

Primary Outcomes (1)

• Change in Fat-Free Mass (kg)

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

  Baseline and Week 12

Secondary Outcomes (21)

• Change in Fat Mass (%)

  Baseline and Week 12

• Change in Body Weight (kg)

  Baseline and Week 12

• Change in Body Mass Index (kg/m²)

  Baseline and Week 12

• Change in Waist Circumference (cm)

  Baseline and Week 12

• Change in Handgrip Strength (kg)

  Baseline and Week 12

Study Arms (6)

Arm 1 - Control Group

NO INTERVENTION

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

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.

Behavioral: Mediterranean Diet Counseling

Arm 3 - Strength Training Group (ST)

EXPERIMENTAL

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.

Behavioral: Supervised Strength Training Program

Arm 4 - Endurance Training Group (ET)

EXPERIMENTAL

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.

Behavioral: Supervised Endurance Training Program

Arm 5 - Combined Training Group (CT)

EXPERIMENTAL

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.

Behavioral: Combined Strength and Endurance Training Program

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

EXPERIMENTAL

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.

Behavioral: Combined Mediterranean Diet and Exercise Program

Interventions

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.

Arm 2 - Mediterranean Diet Group (MD)

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.

Arm 3 - Strength Training Group (ST)

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.

Arm 4 - Endurance Training Group (ET)

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.

Arm 5 - Combined Training Group (CT)

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.

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

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

European Institute Of Exercise and Health

Elche, Alicante, 03203, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Health Sciences

Model Details: Participants will be randomly assigned to one of six parallel intervention arms (control, Mediterranean diet, strength training, endurance training, combined training, or Mediterranean diet plus combined training). The interventions will be carried out simultaneously over 12 weeks, with pre- and post-intervention assessments to evaluate changes in physical, physiological, and psychological parameters.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 10, 2025
• Study Start: September 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

ES (1)