Clinical trial NCT04704856: Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
Official title: Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Stage I-III breastcancer
Neoadjuvant chemotherapy
Exercise
NK-cells
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participatient Rate
timeFrame: 6 weeks
measure: Successful Examined Biopsies Rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Generate preliminary data
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
state: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: VU Medical Center
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Hans van der Vliet, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Laurien Buffart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Marieke ten Tusscher, MSc.
role: STUDY_CHAIR
affiliation: Amsterdam UMC, location VUmc
name: Susanne van der Velde, Dr.
role: PRINCIPAL_INVESTIGATOR
References: