Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor (SPRINT)

Amsterdam UMC, location VUmc

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Supervised exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04704856

2020.253 NL72539.029.20

Details and patient eligibility

About

'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.

Full 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 aerobic and resistance exercise intervention group or a usual care (no exercise) control group, during the first 6 weeks (2 or 3 cycles) of chemotherapy. Patients from the control group will receive care as usual and are requested to maintain their usual daily physical activities. In order to limit contamination (increase of exercise in the control group), non-participation and prevent dropout, the control group will be offered the same 6-week exercise intervention after the tumor biopsy has been taken after 6 weeks.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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