Combined Nutrition and Exercise Interventions in Women With Breast Cancer History (NCT07275957) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Combined Nutrition and Exercise Interventions in Women With Breast Cancer History
Spain120 participantsStarted 2023-09-01
Plain-language 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.
Who can participate
Age range
30 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.