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Breast CancerNEOPRO-SITNCT07464457

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

A study testing Prehabilitation in people with Breast Cancer and Solid Tumor, run by Priv.-Doz. Dr. med. Philipp Lenz at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Breast Cancer, Solid Tumor
What is being tested?
Prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteGermany
Study dates
Mar 2026to Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mira Meyer-Ács contact

+49 251 8349134

mira.meyer-acs@ukmuenster.de

Germany1 site, 1 recruiting

  • University hospital Münster

    Münster, North Rhine-Westphalia, 48149

    Mira Meyer-Ács, +49 251 83 49134, mira.meyer-acs@ukmuenster.de

    Recruiting

Other trials in Germany

About this study

Official title: 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

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

Read the 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.

Being tested
Prehabilitation, standard of care
Keywords
prehabilitation, exercise therapy, psychoonlogic intervention, oncology, solid tumors
Medical subject headings
Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrehabilitationBehavioural

    Targeted exercise and psychooncological program

  • standard of careBehavioural

    Clinical routine as applied in Germany

Study groups in NCT07464457
Study groupRoleWhat they receive
Control armActive comparatorStandard of care
Receives: Behavioral: standard of care
Prehabilitation armExperimentalTargeted execercise and psychooncological program
Receives: Behavioral: Prehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to 14 - 28 days after ablative intervention

Secondary outcomes (10)

  1. Muscle strength

    Muscle strength, assessed using the 30-Second Chair Rise Test during and after ablative interventional therapy.

    Measured: From enrollment to 14 - 28 days after ablative intervention

  2. Handgrip strength

    Muscle strength, assessed using handgrip strength measured by dynamometry during and after ablative interventional therapy.

    Measured: From enrollment to 14 - 28 days after ablative intervention

  3. Psychological distress

    Psychological distress measured using the NCCN Distress Thermometer, a single-item visual analog scale ranging from 0 ("no distress") to 10 ("extreme distress"). A score of ≥4 is commonly used as a threshold for clinically significant distress requiring further evaluation.

    Measured: From enrollment to 6 months after the ablative intervention

  4. Anxiety

    Anxiety using the Generalized Anxiety Disorder Scale (GAD-7), a 7-item measure assessing symptoms of generalized anxiety over the past two weeks. Each item is rated from 0 ("not at all") to 3 ("nearly every day"), yielding a total score range of 0-21. Cut-offs are 5 (mild anxiety), 10 (moderate anxiety), and 15 (severe anxiety).

    Measured: From enrollment to 6 months after the ablative intervention

  5. Depression

    Depression assessed using the Patient Health Questionnaire (PHQ-8), an 8-item instrument measuring depressive symptoms over the past two weeks. Items are rated from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score range of 0-24. Cut-offs are 5 (mild depression), 10 (moderate depression), 15 (moderately severe depression), and 20 (severe depression).

    Measured: From enrollment to 6 months after the ablative intervention

  6. Emotional regulation

    Emotional regulation assessed by the Emotion Regulation Questionnaire Short (ERQ-S), a shortened version of the ERQ assessing two emotion regulation strategies: cognitive reappraisal and expressive suppression. Items are rated on a 7-point Likert scale from 1 ("strongly disagree") to 7 ("strongly agree"). Subscale scores are calculated as mean values, with higher scores indicating greater use of the respective strategy.

    Measured: From enrollment to 6 months after the ablative intervention

  7. Emotion Beliefs

    Beliefs about the usefulness and controllability of emotions assessed by the Emotion Beliefs Questionnaire (EBQ). Items are rated on a 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree"). Subscale and total scores are calculated as mean values, with higher scores reflecting stronger maladaptive beliefs about emotions.

    Measured: From enrollment to 6 months after the ablative intervention

  8. Health-related quality of life

    Health-related quality of life, assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 is a validated, internationally used modular instrument for assessing quality of life in oncology patients. It comprises 30 items covering 15 symptom and functional domains.

    Measured: From enrollment to 6 months after the ablative intervention

  9. Length of hospital stay

    Length of hospital stay, defined as the number of inpatient days during ablative interventional treatment.

    Measured: From ablative intervention up to one month after ablative intervention

  10. Infections

    Infections, with or without the need for inpatient treatment

    Measured: From enrollment to 6 months after the ablative intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionAug 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07464457
Sponsor's protocol ID
2025-1006-f-S
Acronym
NEOPRO-SIT
Status last verified
Mar 2026
First submitted
26 Feb 2026
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD are subject to data protection

Questions about this trial

What is this clinical trial studying?

A study testing Prehabilitation in people with Breast Cancer and Solid Tumor, run by Priv.-Doz. Dr. med. Philipp Lenz at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mira Meyer-Ács (+49 251 8349134, mira.meyer-acs@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical performance using the 6-Minute Walk Test (time frame: From enrollment to 14 - 28 days after ablative intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07464457.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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