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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

December 18, 2020

Last Update Submit

March 21, 2023

Conditions

Breast Cancer

Keywords

Stage I-III breastcancerNeoadjuvant chemotherapyExerciseNK-cells

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Generate preliminary data

    6 weeks

Study Arms (2)

Interventiongroup

ACTIVE COMPARATOR

Interventiongroup, undergo supervised exercise for the first 6 weeks.

Behavioral: Supervised exercise

Controlgroup

NO INTERVENTION

Controlgroup, do not undergo supervised exercise for the first 6 weeks (possibility to undergo supervised exercise after 6 weeks).

Interventions

Supervised exerciseBEHAVIORAL

Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.

Interventiongroup

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStage I-III breastcancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Flevoziekenhuis

Almere Stad, Flevoziekenhuis, 1315RA, Netherlands

Location

VU Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

Location

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Hans van der Vliet, Prof.

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

  • Laurien Buffart, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Marieke ten Tusscher, MSc.

    Amsterdam UMC, location VUmc

    STUDY CHAIR

  • Susanne van der Velde, Dr.

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 18, 2020

First Posted

January 12, 2021

Study Start

January 6, 2021

Primary Completion

July 25, 2022

Study Completion

July 25, 2022

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

POLARIS study (PROSPERO 2013 CRD42013003805)

Shared Documents
ANALYTIC CODE
Time Frame
01-01-2023 t/m 01-01-2025
Access Criteria
anonymous

Locations

NL(2)