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Completed
NCT07275957
Combined Nutrition and Exercise Interventions in Women With Breast Cancer History
Conditions: Breast Cancer Survivors
Sex: Female
Ages: 30 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: University of Alicante
Location: European Institute Of Exercise and Health Elche Alicante
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 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.
Source: ClinicalTrials.gov (NCT07275957). StuddyBuddy aggregates publicly available trial information.