The Munich Adrenaline Cancer Study

NCT04847908 | Completed

• 1 other identifier: TUM
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Observational studies report associations between physical activity and survival in some types of adult cancer. In addition, some exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this study is to analyse changes in adrenaline concentration with a single high-intensity interval exercise intervention on a cycle ergometer in children and adolescents during treatment for cancer and to examine the feasibility of the study concept.

Conditions

Childhood Cancer

Keywords

exercise; metabolomics; high-intensity interval exercise intervention

Outcome Measures

Primary Outcomes (1)

• Changes in adrenaline concentration

  Blood samples are collected at rest pre-exercise (t0) and post-exercise (t1) via a central catheter and prepared for processing by trained personnel (centrifuged, snap-frozen). Both at t0 and t1, 4,9ml blood are taken for adrenaline and lactate concentration (see secondary outcomes). Serum adrenaline concentration is measured with an ELISA kit in mmol/l.

  Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1)

Secondary Outcomes (4)

• Feasibility of the study concept

  Through study completion, on average 14 days

• Lactate concentration

  Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1)

• Heart rate

  Pre-exercise (at rest, t0), during high-intensity interval exercise intervention and post-exercise (within 3 min, t1)

• Physical activity before diagnosis

  Once, pre-intervention

Study Arms (1)

High-intensity interval exercise intervention

EXPERIMENTAL

Change according to definition.

Other: Single high-intensity interval exercise intervention

Interventions

Single high-intensity interval exercise intervention OTHER

Study participants perform a single bout of exercise on a cycle ergometer (high-intensity interval exercise intervention) within the first and third cycle of chemotherapy. Following a 2 minute warm-up, the interval protocol comprises 10 intervals à 15 seconds with high intensity and 60 seconds low intensity in-between. Blood samples are taken at t0 pre-exercise (after a 10 minute rest) and at t1 immediately post-exercise via central catheter (Hickman/port).

High-intensity interval exercise intervention

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• newly diagnosed pediatric cancer or relapse
• aged 6-18 years
• between the first and third cycle of chemotherapy
• diagnosis and treatment at the Kinderklinik München Schwabing, Department of Paediatrics and Children's Cancer Research Centre, Technical University of Munich
• German language
• informed consent as documented by signature

You may not qualify if:

• Any medical contraindication with respect to a high-intensity interval exercise intervention (e.g., cardiovascular complications, comorbidities, bleeding risk, pain, infection, nausea, orthopedic impairment of the lower extremities)
• inability to follow the procedures and understand the intervention and assessment of the study, e.g., due to cognitive impairment, language problems, psychological disorders etc.

Sponsors & Collaborators

• Technical University of Munich: lead
• Helmholtz Zentrum München: collaborator

Study Sites (1)

Kinderklinik München Schwabing, TUM School of Medicine, Department of Paediatrics and Children's Cancer Research Center, Technical University of Munich, Germany

Munich, 80804, Germany

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Irene Teichert-von Lüttichau, PD Dr. med.

  TUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. medic

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 19, 2021
• Study Start: March 1, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

DE (1)