Breast CancerSPRINTNCT04704856
Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
A study testing Supervised exercise in people with Breast Cancer, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Supervised exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- 6 Jan 2021to 25 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Flevoziekenhuis
Almere Stad, Flevoziekenhuis, 1315RA
VU Medical Center
Amsterdam, North Holland, 1081HV
About this study
'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.
Read the 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
- Being tested
- Supervised exercise
- Keywords
- Stage I-III breastcancer, Neoadjuvant chemotherapy, Exercise, NK-cells
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseBehavioural
Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Interventiongroup | Active comparator | Interventiongroup, undergo supervised exercise for the first 6 weeks. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participatient Rate
Percentage of patient actually enrolled in the study of all patients who will be screened
Measured: 6 weeks
Successful Examined Biopsies Rate
Percentage of tumor biopsies that can be examined successfully
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start6 Jan 2021
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans J. van der Vliet, MD, PhD, Amsterdam UMC, location VUmc
- Investigators
- Hans van der Vliet, Prof., Principal investigator, Amsterdam UMC, location VUmcLaurien Buffart, PhD, Principal investigator, Radboud University Medical CenterMarieke ten Tusscher, MSc., Study chair, Amsterdam UMC, location VUmcSusanne van der Velde, Dr., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704856
- Sponsor's protocol ID
- 2020.253 NL72539.029.20
- Acronym
- SPRINT
- Status last verified
- Mar 2023
- First submitted
- 18 Dec 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: POLARIS study (PROSPERO 2013 CRD42013003805)
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
- ClinicalTrials.gov ID
- NCT04704856
- Acronym / sponsor ID
- SPRINT / 2020.253 NL72539.029.20
- Conditions
- Breast Cancer
- Keywords
- Stage I-III breastcancer, Neoadjuvant chemotherapy, Exercise, NK-cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventiongroup | Active comparator | Behavioral: Supervised exerciseInterventiongroup, undergo supervised exercise for the first 6 weeks. |
| Controlgroup | No intervention | –Controlgroup, do not undergo supervised exercise for the first 6 weeks (possibility to undergo supervised exercise after 6 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exerciseSupervised exercise during first 6 weeks of neoadjuvant chemotherapy. | Behavioural | Interventiongroup |
Primary outcome
Participatient Rate
Time frame: 6 weeks
Percentage of patient actually enrolled in the study of all patients who will be screened
Successful Examined Biopsies Rate
Time frame: 6 weeks
Percentage of tumor biopsies that can be examined successfully
1 secondary outcome
Generate preliminary data
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Yes. POLARIS study (PROSPERO 2013 CRD42013003805)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans van der Vliet, Prof. principal investigator
Amsterdam UMC, location VUmc
Laurien Buffart, PhD principal investigator
Radboud University Medical Center
Marieke ten Tusscher, MSc. study chair
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise in people with Breast Cancer, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participatient Rate (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.