Supervised exercise to PRomote Infiltration of NK-cells into the Tumor (SPRINT): a randomized feasibility-trial.

Supervised exercise to PRomote Infiltration of NK-cells into the Tumor (SPRINT): a randomized feasibility-trial. - SPRINT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49331

Enrollment

Registered

2020-10-19

Start date

2021-05-04

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breastcancer breastcarcinoma

Interventions

The intervention group will receive a supervised exercise intervention during neoadjuvant chemotherapy (6 weeks). Supervised one-hour exercise sessions include aerobic and resistance exercises and w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Stage I-III breast cancer * scheduled for neoadjuvant chemotherapy with 2 or 3-weekly Adriamycin/Cyclofosfamide, followed by Paclitaxel weekly +/- trastuzumab, for early (stage I-III) breast cancer * 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

Exclusion criteria: * addition of immuno- or targeted therapy at start 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

Design outcomes

Primary

Measure	Time frame
Feasibility is the primary outcome measure of this study: 1) Recruitment What is the proportion of eligible patients who are willing to participate in this study and undergo an additional tumor biopsy? 2) Quality of tumor material What is the percentage of tumor biopsies that can be assessed successfully from all planned measurements both at baseline and after 6 weeks of neo-adjuvant treatment? We conclude that our pilot-study is feasible if: 1. We achieve a recruitmentrate of at least 20%. 2. At least 50% of the total number of biopsies (both T0 and T1) can be examined successfully on infiltration of NK-cells.	—

Measure

Time frame

Feasibility is the primary outcome measure of this study: 1) Recruitment What is the proportion of eligible patients who are willing to participate in this study and undergo an additional tumor biopsy? 2) Quality of tumor material What is the percentage of tumor biopsies that can be assessed successfully from all planned measurements both at baseline and after 6 weeks of neo-adjuvant treatment? We conclude that our pilot-study is feasible if: 1. We achieve a recruitmentrate of at least 20%. 2. At least 50% of the total number of biopsies (both T0 and T1) can be examined successfully on infiltration of NK-cells.

—

Secondary

Measure	Time frame
Preliminary effects on immune function, IL-6 levels before and after an exercise session and physical fitness. Primary end-point for the preliminary effects is the alteration in number of NK-cells per total number of lymphocytes and in NK-phenotype measured from biopsy tissue. In addition, immune function will be measured from blood.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)