NCT05656651

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 19, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

November 13, 2022

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Subjective Quality of Life

    Once after intervention

  • Fatigue

    Once after intervention

  • Nutritional status

    Once after intervention

Study Arms (2)

Cancer patients

EXPERIMENTAL

Single exercise intervention following a HIIT protocol, duration \~20 mins

Behavioral: High intensity interval exercise training

Healthy adults

ACTIVE COMPARATOR

Single exercise intervention following a HIIT protocol, duration \~20 mins

Behavioral: High intensity interval exercise training

Interventions

Endurance training adapted to age, resting heart rate

Also known as: HIIT, Exercise
Cancer patientsHealthy adults

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

  • Deppe 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.

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Miriam Götte, Dr.

    University Hospital, Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2022

First Posted

December 19, 2022

Study Start

December 19, 2022

Primary Completion

July 31, 2024

Study Completion

July 1, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations