Clinical trial · Interventional
Combined Nutrition and Exercise Interventions in Women With Breast Cancer History
Study of the Effects of Implementing Dietary-nutritional Strategies and an Exercise Program at the Physical, Physiological, and Psychological Level in Women With a History of Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Mediterranean Diet and Exercise Program | Behavioral | — | UNRESOLVED |
| Combined Strength and Endurance Training Program | Behavioral | — | UNRESOLVED |
| Mediterranean Diet Counseling | Behavioral | — | UNRESOLVED |
| Supervised Endurance Training Program | Behavioral | — | UNRESOLVED |
| Supervised Strength Training Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- Arm 1 - Control 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.
- type
- EXPERIMENTAL
- label
- Arm 2 - Mediterranean Diet Group (MD)
- 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.
- interventionNames
- Behavioral: Mediterranean Diet Counseling
- type
- EXPERIMENTAL
- label
- Arm 3 - Strength Training Group (ST)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available