Acute Immunological Effects of Exercise in Cancer Patients

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05656651

Studienbeginn:
Dezember 2022

Letztes Update:
22.12.2022

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 2

Sponsor:
Universität Duisburg-Essen

Collaborator:
-

Studienleiter

Miriam Götte, Dr.
Principal Investigator
University Hospital, Essen

Kontakt

Miriam Götte, Dr.
Kontakt:
Phone: +492017238083
E-Mail: miriam.goette@uk-essen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Isabella Deppe
Phone: 0049 201 7238083
E-Mail: isabella.deppe@stud.uni-due.de

Fabian Kiehl
Phone: 0049 201 7238083
E-Mail: fabian.kiehl@stud.uni-due.de» Ansprechpartner anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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

Secondary outcome:

1. 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)

2. Fatigue (Time Frame - Once after intervention):
Fatigue (EORTC QLQ FA12 Fatigue questionnaire range 0 - 100, higher score = worse outcome)

3. Nutritional status (Time Frame - Once after intervention):
Mini Nutritional Assessment (MNA range 0 - 14 points), lower score = worse

Studien-Arme

Experimental: Cancer patients
Single exercise intervention following a HIIT protocol, duration ~20 mins
Active Comparator: Healthy adults
Single exercise intervention following a HIIT protocol, duration ~20 mins

Geprüfte Regime

High intensity interval exercise training (HIIT, Exercise):
Endurance training adapted to age, resting heart rate

Quelle: ClinicalTrials.gov

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