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Brief Title: 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 ID: NCT04704856
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Flevoziekenhuis, Almere, Flevoziekenhuis, Netherlands
VU Medical Center, Amsterdam, Noord-Holland, Netherlands
Name: Hans van der Vliet, Prof.
Affiliation: Amsterdam UMC, location VUmc
Role: PRINCIPAL_INVESTIGATOR
Name: Laurien Buffart, PhD
Affiliation: Radboud University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Marieke ten Tusscher, MSc.
Affiliation: Amsterdam UMC, location VUmc
Role: STUDY_CHAIR
Name: Susanne van der Velde, Dr.
Affiliation: Amsterdam UMC, location VUmc
Role: PRINCIPAL_INVESTIGATOR