Physical exercise program for head and neck cancer patients
The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study
This study tests if a 10-week exercise program can help people with head and neck cancer feel stronger and improve their quality of life while they are receiving treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute Verbeeten Academic / other |
| Locations | 1 site (Tilburg, North Brabant) |
| Trial ID | NCT05988060 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effects of a 10-week physical exercise intervention on patients with head and neck cancer undergoing radiotherapy, chemoradiation, or bioradiation. Participants will be randomized into two groups: one receiving the exercise intervention twice a week and the other not receiving it. The study will assess various outcomes including physical performance, muscle strength, fatigue, quality of life, and treatment tolerability. The goal is to determine if the exercise program can improve these factors compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with head and neck cancer scheduled for radiotherapy or chemoradiation.
Not a fit: Patients with recurrent head and neck cancer or secondary head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance physical performance and quality of life for patients undergoing treatment for head and neck cancer.
How similar studies have performed: Other studies have shown positive outcomes with physical exercise interventions in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients with HNC who are scheduled for (C/B)RT, 2. ≥18 years of age, 3. sufficient Dutch writing and reading skills, 4. a Karnofsky performance status (KPS) \>60, 5. able to walk ≥60m without a mobility aid, and 6. no contraindication for physical activity as measured with the physical activity readiness questionnaire (PAR-Q). Exclusion Criteria: 1. recurrence of HNC and/or 2. secondary HNC.
Where this trial is running
Tilburg, North Brabant
- Instituut Verbeeten — Tilburg, North Brabant, Netherlands (Recruiting)
Study contacts
- Principal investigator: Yvette Kriellaars, Msc. — Instituut Verbeeten
- Study coordinator: Caroline Speksnijder, Dr.
- Email: C.M.Speksnijder@umcutrecht.nl
- Phone: +3188758040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.