NCT07464457

Effects of Neoadjuvant Prehabilitation on Post-Interventional Physical and Psychological Outcomes in Oncology Patients 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Priv.-Doz. Dr. med. Philipp Lenz · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of NEOPRO-SIT is to establish and evaluate a neoadjuvant prehabilitation program comprised of targeted exercise therapy and structured psycho-oncological support in patients with solid tumors. The main question is: Will targeted exercise therapy and structured psycho-oncological support increase both physical and psychological capacity as well of quality of life compared to standard of care in a prehabilitation setting? Researchers will: compare a prehabilitation program to standard of care Participants will: receive either standard or care or a comprehensive prehabilitation program

Detailed description

The project NEOPRO-SIT aims to establish and evaluate a neoadjuvant prehabilitation program comprised of targeted exercise therapy and structured psycho-oncological support in patients with solid tumors. NEOPRO-SIT is a prospective, two-arm, controlled, single-center interventional study evaluating the effectiveness of neoadjuvant prehabilitation in patients with solid tumors. The study compares the standard of care with a structured, closely supervised prehabilitation program. A total of 125 patients will be enrolled in this study. The NEOPRO-SIT project evaluates whether a structured, supervised prehabilitation program during neoadjuvant therapy provides additional physical and psychological benefits compared with a low-resource consultation-based approach. Despite the limitations of a sequential non-randomized design, the study aims to establish a feasible, standardized prehabilitation concept that could improve patient outcomes and support more efficient integration of supportive care into routine oncology.

Conditions

• Breast Cancer
• Solid Tumor

Interventions

Type	Name	Description
BEHAVIORAL	Prehabilitation	Targeted exercise and psychooncological program
BEHAVIORAL	standard of care	Clinical routine as applied in Germany

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-08-01
• Completion: 2029-10-01
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: Germany