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

'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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Supervised exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Flevoziekenhuis
    • Almere, Flevoziekenhuis, Netherlands, 1315RA
      • Flevoziekenhuis
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081HV
      • VU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Hans van der Vliet, Prof., Amsterdam UMC, location VUmc; Principal Investigator: Laurien Buffart, PhD, Radboud University Medical Center; Study Chair: Marieke ten Tusscher, MSc., Amsterdam UMC, location VUmc; Principal Investigator: Susanne van der Velde, Dr., Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Neoadjuvant chemotherapy; NK-cells; Stage I-III breastcancer
• Other Study ID Numbers: 2020.253 NL72539.029.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: POLARIS study (PROSPERO 2013 CRD42013003805)
• IPD Sharing Time Frame: 01-01-2023 t/m 01-01-2025
• IPD Sharing Access Criteria: anonymous
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No