Status:
COMPLETED
Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 t...
Detailed Description
This is a multicenter randomized controlled feasibility trial, in which 20 women with breast cancer scheduled for neoadjuvant 2 or 3 weekly AC-T(H) chemotherapy will be randomized into a combined aero...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04704856
Start Date
January 6 2021
End Date
July 25 2022
Last Update
March 24 2023
Active Locations (2)
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1
Flevoziekenhuis
Almere Stad, Flevoziekenhuis, Netherlands, 1315RA
2
VU Medical Center
Amsterdam, North Holland, Netherlands, 1081HV