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

NCT07464457 | Recruiting

• 1 other identifier: 2025-1006-f-S
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer; Solid Tumor

Keywords

prehabilitation; exercise therapy; psychoonlogic intervention; oncology; solid tumors

Outcome Measures

Primary Outcomes (1)

• Physical performance using the 6-Minute Walk Test

  Physical performance at post-intervention (14-28 days after the ablative intervention), assessed using the 6-Minute Walk Test.

  From enrollment to 14 - 28 days after ablative intervention

Secondary Outcomes (10)

• Muscle strength

  From enrollment to 14 - 28 days after ablative intervention

• Handgrip strength

  From enrollment to 14 - 28 days after ablative intervention

• Psychological distress

  From enrollment to 6 months after the ablative intervention

• Anxiety

  From enrollment to 6 months after the ablative intervention

• Depression

  From enrollment to 6 months after the ablative intervention

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Standard of care

Behavioral: standard of care

Prehabilitation arm

EXPERIMENTAL

Targeted execercise and psychooncological program

Behavioral: Prehabilitation

Interventions

Prehabilitation BEHAVIORAL

Targeted exercise and psychooncological program

Prehabilitation arm

standard of care BEHAVIORAL

Clinical routine as applied in Germany

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Priv.-Doz. Dr. med. Philipp Lenz: lead

Study Sites (1)

University hospital Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Preoperative Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Annalen Bleckmann, Univ.-Prof. Dr. med.

  University hospital Münster

  PRINCIPAL INVESTIGATOR

• Philipp Lenz, Prof. Dr. med.

  University hospital Münster

  PRINCIPAL INVESTIGATOR

• Markus Ramm, Dr. rer. nat.

  University hospital Münster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mira Meyer-Ács

CONTACT

+49 251 8349134; mira.meyer-acs@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO of the West German Cancer Center

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)