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NCT05656651 Clinical Trial

Acute Immunological Effects of Exercise in Cancer Patients

Cancer Clinical Trial

— ACTIVE  

Official title:
ACTIVE- Acute Effects of a Single Physical Exercise Intervention on Immune Cells and Inflammation in Cancer Patients and a Healthy Comparison Group

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05656651
Other study ID # ACTIVE
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 19, 2022
Est. completion date December 2023

Study information
Verified date December 2022
Source Universität Duisburg-Essen
Contact Miriam Götte, Dr.
Phone +492017238083
Email miriam.goette@uk-essen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• High intensity interval exercise training
Endurance training adapted to age, resting heart rate

Locations
Country Name City State
Germany University Hospital Essen Essen NRW

Sponsors (1)
Lead Sponsor Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Natural Killer Cells NK cells, subgroups and innate lymphoid cells Change from pre Intervention to immediately after intervention and 1 hour post intervention
Secondary Subjective Quality of Life Quality of Life (EORTC QLQ-C30, questionnaire score from 0 - 100, higher score = better quality of life) Once after intervention
Secondary Fatigue Fatigue (EORTC QLQ FA12 Fatigue questionnaire range 0 - 100, higher score = worse outcome) Once after intervention
Secondary Nutritional status Mini Nutritional Assessment (MNA range 0 - 14 points), lower score = worse Once after intervention
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