Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor (NCT04704856) | Clinical Trial Compass
CompletedNot Applicable
Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
Netherlands20 participantsStarted 2021-01-06
Plain-language summary
'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.
Who can participate
Age range18 Years
SexFEMALE
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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