NCT04704856

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Supervised exercise	Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.

Timeline

• Start date: 2021-01-06
• Primary completion: 2022-07-25
• Completion: 2022-07-25
• First posted: 2021-01-12
• Last updated: 2023-03-24

Locations

2 sites across 1 country: Netherlands