Multimodal prehabilitation combining exercise, nutrition, and psychological support to improve chemotherapy response in early breast cancer
Multimodal Intervention During Neoadjuvant Chemotherapy in Patients With Early-breast Cancer as a Strategy to Improve Treatment Response: DIANA Trial (Multimodal Prehabilitation: DIet, ANxiety Control Psychotherapy, Physical Activity)
This trial will try a combined program of exercise, nutrition, and psychological support during neoadjuvant chemotherapy to see if it improves tumor response in women with early-stage (I–III) breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT07107594 on ClinicalTrials.gov |
What this trial studies
This randomized trial will enroll 214 women with non-metastatic (stage I–III) breast cancer who are scheduled for neoadjuvant chemotherapy and assign them 1:1 to either a multimodal prehabilitation program or standard care. The intervention group will receive structured physical exercise, nutritional guidance, and psychological support during the 4–6 months of chemotherapy, while the control group will receive routine clinical management. The primary comparison is the pathological response to chemotherapy at the time of surgery, with secondary outcomes likely including quality of life and treatment tolerance. The program seeks to optimize patients' physical and emotional condition and may favorably affect tumor microenvironment factors that influence treatment response.
Who should consider this trial
Good fit: Adult women (≥18 years) with non-metastatic (stage I–III) breast cancer who are planned for neoadjuvant chemotherapy and are physically able to perform moderate-to-high intensity exercise.
Not a fit: Patients with metastatic (stage IV) disease, those unable to exercise safely, pregnant or breastfeeding women, men, or patients already doing more than 150 minutes per week of moderate-to-vigorous aerobic exercise are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase rates of complete pathological response to neoadjuvant chemotherapy, potentially improving long-term outcomes and guiding postoperative treatment decisions.
How similar studies have performed: Individual components such as exercise, nutritional support, and psychological interventions have shown benefits for quality of life and treatment tolerance in breast cancer, but robust evidence that combined multimodal prehabilitation improves pathological chemotherapy response is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed diagnosis of non-metastatic breast cancer: stages cT1-T4, cN0-N3, M0, and candidates for neoadjuvant chemotherapy (NAC). * Age ≥ 18 years. * Signed informed consent. Exclusion Criteria: * Contraindication or physical inability to perform moderate-to-high intensity physical exercise. * Pregnant or breastfeeding patients. * Presence of other active synchronous neoplasms. * Metastatic breast cancer (stage IV). * Patients already engaging in regular physical exercise: more than 150 minutes of moderate or intense aerobic exercise per week. * Male breast cancer patients. * Personal history of a previous malignancy treated with chemotherapy. * Severe or poorly controlled psychiatric illness (including uncontrolled active substance abuse).
Where this trial is running
Barcelona
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Helena Castillo Espín, MD
- Email: hcastillo@clinic.cat
- Phone: +34 651024667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.