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

Amsterdam UMC, location VUmc20 enrolled

Overview

'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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Supervised exerciseBEHAVIORAL

Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Flevoziekenhuis

Almere Stad, Flevoziekenhuis, Netherlands

VU Medical Center

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

Participatient Rate

Percentage of patient actually enrolled in the study of all patients who will be screened

Time frame: 6 weeks

Successful Examined Biopsies Rate

Percentage of tumor biopsies that can be examined successfully

Time frame: 6 weeks

Secondary Outcomes

Generate preliminary data

on the potential effects of exercise on immune function (Tumor tissue will be investigated by immunohistochemistry (IHC) to assess immune cell infiltration into the tumor with a specific focus on NK-cell frequency and phenotype) assessed in the tumor and in blood.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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