Acute Immunological Effects of Exercise in Cancer Patients (ACTIVE)

May 12, 2026 updated by: Miriam Götte, Universität Duisburg-Essen

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
        • University Hospital Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adolescents and young adults >14 years of age
  • undergoing acute cancer treatment (chemotherapy)
  • signed informed consent

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancer patients
Single exercise intervention following a HIIT protocol, duration ~20 mins
Behavioral: High intensity interval exercise training
Endurance training adapted to age, resting heart rate
Other Names:
  • HIIT, Exercise
Active Comparator: Healthy adults
Single exercise intervention following a HIIT protocol, duration ~20 mins
Behavioral: High intensity interval exercise training
Endurance training adapted to age, resting heart rate
Other Names:
  • HIIT, Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from pre Intervention to immediately after intervention and 1 hour post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Quality of Life
Time Frame: Once after intervention
Quality of Life (EORTC QLQ-C30, questionnaire score from 0 - 100, higher score = better quality of life)
Once after intervention
Fatigue
Time Frame: Once after intervention
Fatigue (EORTC QLQ FA12 Fatigue questionnaire range 0 - 100, higher score = worse outcome)
Once after intervention
Nutritional status
Time Frame: Once after intervention
Mini Nutritional Assessment (MNA range 0 - 14 points), lower score = worse
Once after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Investigators

  • Principal Investigator: Miriam Götte, Dr., University Hospital, Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Actual)

July 31, 2024

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIVE (Nationwide Children's Hospital Intramural Grant - 292913)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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