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

Study Overview
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Brief Summary
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'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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Supervised exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventiongroup<br>Interventiongroup, undergo supervised exercise for the first 6 weeks. | Behavioral: Supervised exercise<br>* Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.<br>|
| No Intervention: Controlgroup<br>Controlgroup, do not undergo supervised exercise for the first 6 weeks (possibility to undergo supervised exercise after 6 weeks). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participatient Rate | Percentage of patient actually enrolled in the study of all patients who will be screened | 6 weeks | 
| Successful Examined Biopsies Rate | Percentage of tumor biopsies that can be examined successfully | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage I-III breastcancer, Neoadjuvant chemotherapy, Exercise, NK-cells