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

Breast Cancer Clinical Trial

— SPRINT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704856
• Other study ID #: 2020.253 NL72539.029.20
• Status: Completed
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: March 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 25, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Supervised exercise
Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere	Flevoziekenhuis
Netherlands	VU Medical Center	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participatient Rate	Percentage of patient actually enrolled in the study of all patients who will be screened	6 weeks
Primary	Successful Examined Biopsies Rate	Percentage of tumor biopsies that can be examined successfully	6 weeks
Secondary	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