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Clinical Trials in Spain / NCT07275957
Active, not recruiting Not applicable

Combined Nutrition and Exercise Interventions in Women With Breast Cancer History

NCT07275957 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-09-01
Last updated
2026-02-04

Condition(s) studied

Breast Cancer Survivors

Investigational drug(s) / intervention(s)

Mediterranean Diet CounselingSupervised Strength Training ProgramSupervised Endurance Training ProgramCombined Strength and Endurance Training ProgramCombined Mediterranean Diet and Exercise Program

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.

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.

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.

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
30 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
European Institute Of Exercise and Health Elche Alicante

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07275957 on ClinicalTrials.gov ↗ ← All trials in Spain