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NCT05988060Recruiting

Physical Exercise for Patients With Head and Neck Cancer

The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study

Source: ClinicalTrials.gov · Last updated 14 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
112 (estimated)
First submitted
20 Jul 2023
Start date
9 Nov 2022
Primary completion date
9 Nov 2025
Lead sponsor
Institute Verbeeten
NCT number
NCT05988060

What you commit to

  • Study type: Interventional
  • Planned participants: 112
  • From 9 Nov 2022 to the primary completion date, 9 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • recurrence of HNC and/or
  • secondary HNC.

Who the study is looking for

  • patients with HNC who are scheduled for (C/B)RT,
  • ≥18 years of age,
  • sufficient Dutch writing and reading skills,
  • a Karnofsky performance status (KPS) \>60,
  • able to walk ≥60m without a mobility aid, and
  • no contraindication for physical activity as measured with the physical activity readiness questionnaire (PAR-Q).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Instituut Verbeeten
Coordinator of this site? Confirm its status
TilburgNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.