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NCT05988060: VITAL

Physical Exercise for Patients With Head and Neck Cancer

Recruiting now NA Last updated 14 August 2023
What this trial tests

NA trial testing Experimental Intervention in Head and Neck Cancer in 112 participants. Currently enrolling.

Timeline
9 November 2022
Primary endpoint
9 November 2025
9 November 2026

Quick facts

Lead sponsorInstitute Verbeeten
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment112
Start date9 November 2022
Primary completion9 November 2025
Estimated completion9 November 2026
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Institute Verbeeten

Who can join

18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT). Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study.
    Kriellaars Y, Vermaire JA, Beugeling M, Poorter R, et al · · 2024 · PMID 38561708 · DOI 10.1186/s12885-024-12172-2
  2. The effect of physical exercise during radiotherapy on physical functioning in patients with head and neck cancer: a trial within cohorts, the VITAL study
    Kriellaars Y, Vermaire JA, Beugeling M, Poorter R, et al · · 2023 · DOI 10.21203/rs.3.rs-3331334/v1

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Other trials of Experimental Intervention

Trials testing the same drug.

Other recruiting trials for Head and Neck Cancer

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05988060.

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