CancerPhase 2ACTIVENCT05656651
Acute Immunological Effects of Exercise in Cancer Patients
A Phase 2 study testing High intensity interval exercise training in people with Cancer, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
The aim of the study is to evaluate and compare immune response to a single exercise intervention in cancer patients and healthy age-maged individuals. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- High intensity interval exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 19 Dec 2022to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescents and young adults >14 years of age
- undergoing acute cancer treatment (chemotherapy)
- signed informed consent
Who cannot join
- Inability to follow and implement test instructions
- medical contraindication to HIIT on cycle ergometer
- chemotherapeutic treatment 48 h prior
- Hb <8g/dl; platelets < 20,000/ul.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACTIVE- Acute Effects of a Single Physical Exercise Intervention on Immune Cells and Inflammation in Cancer Patients and a Healthy Comparison Group
The aim of the study is to evaluate and compare immune response to a single exercise intervention in cancer patients and healthy age-maged individuals.
- Conditions
- Cancer
- Being tested
- High intensity interval exercise training
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval exercise trainingBehavioural
Also called HIIT, Exercise
Endurance training adapted to age, resting heart rate
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Experimental | Single exercise intervention following a HIIT protocol, duration ~20 mins Receives: Behavioral: High intensity interval exercise training |
| Healthy adults | Active comparator | Single exercise intervention following a HIIT protocol, duration ~20 mins Receives: Behavioral: High intensity interval exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Natural Killer Cells
NK cells, subgroups and innate lymphoid cells
Measured: Change from pre Intervention to immediately after intervention and 1 hour post intervention
Secondary outcomes (3)
Subjective Quality of Life
Quality of Life (EORTC QLQ-C30, questionnaire score from 0 - 100, higher score = better quality of life)
Measured: Once after intervention
Fatigue
Fatigue (EORTC QLQ FA12 Fatigue questionnaire range 0 - 100, higher score = worse outcome)
Measured: Once after intervention
Nutritional status
Mini Nutritional Assessment (MNA range 0 - 14 points), lower score = worse
Measured: Once after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start19 Dec 2022
- Primary completion31 Jul 2024
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Götte, Universität Duisburg-Essen
- Investigators
- Miriam Götte, Dr., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656651
- Sponsor's protocol ID
- ACTIVE
- Acronym
- ACTIVE
- Status last verified
- May 2026
- First submitted
- 13 Nov 2022
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiehl F, De Lazzari N, Beller R, Deppe I, Bennstein SB, Botzenhardt S, Salvador Comino MR, Tewes M, Gotte M. High-Intensity Interval Training Boosts Immune Cells in Advanced Cancer Patients and Healthy Controls: Implications for Cancer Care. Cancer Med. 2026 Jun;15(6):e71977. doi: 10.1002/cam4.71977.
PubMed 42233178Deppe I, Beller R, Kiehl F, Lazzari N, Bennstein SB, Reinhardt D, Dirksen U, Gotte M. The impact of a single HIIT intervention on the mobilization of NK cells and ILCs in adolescents and young adults (AYA) undergoing cancer treatment: an interventional controlled trial. BMC Cancer. 2025 Apr 14;25(1):689. doi: 10.1186/s12885-025-14058-3.
PubMed 40229731
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIVE- Acute Effects of a Single Physical Exercise Intervention on Immune Cells and Inflammation in Cancer Patients and a Healthy Comparison Group
- ClinicalTrials.gov ID
- NCT05656651
- Acronym / sponsor ID
- ACTIVE / ACTIVE
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Dec 2022 (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.
The aim of the study is to evaluate and compare immune response to a single exercise intervention in cancer patients and healthy age-maged individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | Experimental | Behavioral: High intensity interval exercise trainingSingle exercise intervention following a HIIT protocol, duration ~20 mins |
| Healthy adults | Active comparator | Behavioral: High intensity interval exercise trainingSingle exercise intervention following a HIIT protocol, duration ~20 mins |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adolescents and young adults >14 years of age
- undergoing acute cancer treatment (chemotherapy)
- signed informed consent
Key exclusion criteria (4 listed)
- Inability to follow and implement test instructions
- medical contraindication to HIIT on cycle ergometer
- chemotherapeutic treatment 48 h prior
- Hb <8g/dl; platelets < 20,000/ul.
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 |
|---|---|---|
| High intensity interval exercise trainingAlso: HIIT, ExerciseEndurance training adapted to age, resting heart rate | Behavioural | Cancer patients, Healthy adults |
Primary outcome
Number of Natural Killer Cells
Time frame: Change from pre Intervention to immediately after intervention and 1 hour post intervention
NK cells, subgroups and innate lymphoid cells
3 secondary outcomes
Subjective Quality of Life
Time frame: Once after intervention
Fatigue
Time frame: Once after intervention
Nutritional status
Time frame: Once after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 42233178Kiehl F, De Lazzari N, Beller R, Deppe I, Bennstein SB, Botzenhardt S, Salvador Comino MR, Tewes M, Gotte M. High-Intensity Interval Training Boosts Immune Cells in Advanced Cancer Patients and Healthy Controls: Implications for Cancer Care. Cancer Med. 2026 Jun;15(6):e71977. doi: 10.1002/cam4.71977.
- Derived from this study: PubMed 40229731Deppe I, Beller R, Kiehl F, Lazzari N, Bennstein SB, Reinhardt D, Dirksen U, Gotte M. The impact of a single HIIT intervention on the mobilization of NK cells and ILCs in adolescents and young adults (AYA) undergoing cancer treatment: an interventional controlled trial. BMC Cancer. 2025 Apr 14;25(1):689. doi: 10.1186/s12885-025-14058-3.
- Individual participant dataSharing planned: No
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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.
Miriam Götte, Dr. principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High intensity interval exercise training in people with Cancer, run by Universität Duisburg-Essen at 1 site in Germany.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of Natural Killer Cells (time frame: Change from pre Intervention to immediately after intervention and 1 hour post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656651, which also lists 2 linked publications.
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 15 May 2026.