Clinical trial · Interventional
A Study of Exercise Therapy in People With Solid Tumor Cancer
Neoadjuvant Exercise Therapy in Solid Tumors: A Phase 1b Dose Expansion Trial
NCT06597786CI-TRIAL-00087266withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Focusing on other studies
Summary
Brief summary (as posted)
The purpose of this study is to find out whether exercise therapy is an effective and safe treatment that causes few or mild side effects when done before standard surgery for solid tumor cancer. The researchers will also study whether the program is feasible (practical) by tracking how well participants follow the program.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exercise therapy
- description
- Exercise therapy will comprise individualized treadmill walking delivered up to 5 times weekly (over a 7-day period) to achieve a weekly cumulative dose of 225 minutes per week. The minimum treatment period will be 3 weeks. Exercise therapy will be administered via a patient-centric, decentralized platform: Digital Platform for Exercise (DPEx). DPEx will permit all study procedures to be conducted remotely in patients' homes.
- interventionNames
- Other: Exercise therapy
Primary outcomes (1)
- measure
- change in Ki67 values
- timeFrame
- up to 3 years
- description
- With at least one pretreatment (baseline) or postintervention measurement of Ki67 will be considered evaluable. To characterize biological activity of neoadjuvant exercise therapy as defined by the change in tumor cell proliferation marker (Ki67) evaluated in paired formalin-fixed paraffin embedded (FFPE) tumor samples obtained before (diagnostic biopsy) and after (surgical resection) exercise therapy. The biopsies will be collected as part of the standard medical care.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed (on preoperative biopsy), resectable, treatment naïve cancer of one of the following types: head and neck, lung, renal, liver, colorectal, gastric, ovarian, melanoma, pancreas, or breast cancer. * Age ≥18 years. * An interval of ≥3 weeks until planned surgical resection; surgery will not be delayed to accommodate the minimum length of exercise therapy intervention in any circumstance. * Measurable disease based on standard of care radiology scans or confirmation by the surgeon. * Body weight ≤ 385 lbs (≤ 174 kg) * Non-exercisers, defined as ≤60 minutes of moderate or vigorous exercise/week based on self-report using a validated survey. * Cleared for moderate-intensity exercise therapy using the Physical Activity Readiness Questionnaire (PAR-Q)+ with screening clearance provided at the discretion of the PI/exercise physiologist. * Willingness to comply with all study-related procedures Exclusion Criteria: * Distant metastases. * Receiving any form of antitumor therapy. * Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes. * Any other diagnosis of invasive cancer currently requiring active treatment. * Any other condition (e.g., pregnancy) or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.
References
Publications (0)
Data not yet available
No reference posted for this study.