Neoadjuvant prehabilitation to improve physical and mental recovery for people with solid tumors
Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients With Solid Tumors: A Prospective, Two-arm, Controlled, Monocentric Interventional Study
This trial tests whether a supervised exercise program plus structured psycho-oncological support before surgery or radiotherapy helps adults with solid tumors stay fitter and feel better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital Muenster Academic / other |
| Locations | 1 site (Münster, North Rhine-Westphalia) |
| Trial ID | NCT07464457 on ClinicalTrials.gov |
What this trial studies
NEOPRO-SIT is a prospective, two-arm, controlled, single-center interventional study enrolling 125 patients with solid tumors, with a focus on breast cancer. Participants receive either usual care (a low-resource consultation-based approach) or a structured, closely supervised prehabilitation program combining targeted exercise therapy and psycho-oncological support during the neoadjuvant period. The trial uses a sequential non-randomized design to compare physical capacity, psychological capacity, and quality of life outcomes between groups. The aim is to create a feasible, standardized prehabilitation concept that can be integrated into routine oncology care if beneficial.
Who should consider this trial
Good fit: Adults (over 18) with curative-intent treatment plans for solid tumors (especially breast cancer), ECOG 0–2, able to participate in exercise and complete questionnaires, and able to attend the program at the study site.
Not a fit: Patients with medical contraindications to physical activity, severe cardiac or pulmonary disease, those who are pregnant or breastfeeding, have acute infections, lack capacity to consent, or are ineligible for curative-intent treatment are unlikely to benefit or to be eligible.
Why it matters
Potential benefit: If successful, the program could improve preoperative fitness, reduce psychological distress, and enhance quality of life and recovery after local cancer treatment.
How similar studies have performed: Similar prehabilitation programs have shown promising improvements in fitness, postoperative outcomes, and quality of life in smaller studies, but broader evidence is still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with solid tumors (focus on breastcancer) * Curative-intent multimodal treatment concept with local surgical or radiotherapeutic ablation * Working age and \> 18 years * ECOG 0-2 * Sufficient language skills to understand questionnaires/training instructions Exclusion Criteria: * Severe cardiac or pulmonary comorbidities that do not allow participation in the program * Medical contraindications for physical activity * Lack of patient capacity to consent * Pregnancy/breastfeeding * Acute infections/fever * Participation in another clinical intervention study
Where this trial is running
Münster, North Rhine-Westphalia
- University hospital Münster — Münster, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Annalen Bleckmann, Univ.-Prof. Dr. med. — University hospital Münster
- Study coordinator: Mira Meyer-Ács
- Email: mira.meyer-acs@ukmuenster.de
- Phone: +49 251 8349134
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.