Clinical trial · Interventional
Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
NCT04704856CI-TRIAL-00065015SPRINTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
'Supervised exercise to PRomote Infiltration of NK-cells into the Tumor? The objective of this feasibility study is to 1) study trial feasibility in terms of patient enrollment and the percentage of tumor biopsies that can be examined successfully, and 2) generate preliminary data on the potential effects of exercise on immune function assessed in the tumor and in blood.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supervised exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Interventiongroup
- description
- Interventiongroup, undergo supervised exercise for the first 6 weeks.
- interventionNames
- Behavioral: Supervised exercise
- type
- NO_INTERVENTION
- label
- Controlgroup
- description
- Controlgroup, do not undergo supervised exercise for the first 6 weeks (possibility to undergo supervised exercise after 6 weeks).
Primary outcomes (2)
- measure
- Participatient Rate
- timeFrame
- 6 weeks
- description
- Percentage of patient actually enrolled in the study of all patients who will be screened
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * stage I-III breast cancer * scheduled for neoadjuvant chemotherapy with 2 or 3-weekly Adriamycin/Cyclofosfamide, followed by Paclitaxel weekly +/- trastuzumab * willing to undergo an additional ultrasound guided biopsy * ECOG-performance score ≤ 2 (able to perform basic activities of daily living such as walking or biking) Exclusion Criteria: * addition of immuno- or targeted therapy at start of neoadjuvant chemotherapy * currently participating in structured vigorous aerobic exercise and/or resistance exercise (≥2 days per week). * cognitive disorder or severe emotional instability * presence of other disabling co-morbidity that might hamper physical exercise e.g. heart failure (NYHA classes 3 and 4), chronic obstructive pulmonary disease (COPD, gold 3 and 4), orthopaedic conditions and neurological disorders (e.g., hernia, paresis, amputation, active rheumatoid arthritis); * immunosuppressive medication (e.g. corticosteroids (other than used as part of standard chemotherapy premedication protocol), cyclosporine) * immunodeficiency (primary or secondary) * impossibility to perform an ultrasound-guided biopsy of the tumor
References
Publications (0)
Data not yet available
No reference posted for this study.