Physical Exercise for Patients With Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Intervention.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study
Overview
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).
Interventions
- Other Experimental Intervention
Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology. Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.
Primary outcome measures
- physical performance [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
Secondary outcome measures (12)
- Muscle strength [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Muscle strength [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Muscle strength [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Health Related Quality of Life [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Health Related Quality of Life [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Health Related Quality of Life [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Fatigue [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Body composition [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Nutrition status [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Physical activity [Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Tolerability of radiotherapy, chemoradiation or bioradiation [Time frame: M1 (12 weeks), M2 (6 months), M3 (12 months)]
- socio-demographic data and medical data [Time frame: M0 (baseline/before (C/B)RT)]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- recurrence of HNC and/or
- secondary HNC.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Netherlands · 1 center
- Instituut Verbeeten — Tilburg
Publications
- Kriellaars Y, Vermaire JA, Beugeling M, Poorter R, Drijvers J, Speksnijder CM. 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. BMC Cancer. 2024 Apr 1;24(1):403. doi: 10.1186/s12885-024-12172-2. PMID 38561708
Identifiers
NCT: NCT05988060 · NL79549.028.21