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

NCT ID: NCT04704856

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2022-07-25

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventiongroup

Interventiongroup, undergo supervised exercise for the first 6 weeks.

Group Type: ACTIVE_COMPARATOR

Supervised exercise

Intervention Type: BEHAVIORAL

Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.

Controlgroup

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supervised exercise

Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Hans J. van der Vliet, MD, PhD

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans van der Vliet, Prof.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Laurien Buffart, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Marieke ten Tusscher, MSc.

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Susanne van der Velde, Dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

Flevoziekenhuis

Almere Stad, Flevoziekenhuis, Netherlands

VU Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2020.253 NL72539.029.20

Identifier Type: -

Identifier Source: org_study_id