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
- Diseases
- Head and neck cancer
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituut Verbeeten Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.