Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients who were randomized in the PEI group and accepted the invitation
- description
- The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.
- interventionNames
- Other: Experimental Intervention
- type
- NO_INTERVENTION
- label
- Patients who were not randomized in the PEI group
- description
- Patients will receive usual care.
Primary outcomes (1)
- measure
- physical performance
- timeFrame
- M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
- description
- six minute walking test
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKriellaars 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