The effect of (chemo- or bio)radiation on functional capacity, fatigue and quality of life in patients with head and neck cancer: a trial within cohorts, the VITAL study.

• Conditions: head and neck cancer; Physical performance; 10027656; 10019190

• Registration Number: NL-OMON50761
• Lead Sponsor: Verbeeten Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 116

Inclusion Criteria

- Patients with head and neck cancer who are scheduled for (chemo- or
bio)radiation
- Patients >=18 years of age
- Patients with sufficient Dutch writing and reading skills
- Karnofsky Performance status >60
- Able to walk >=60 m without a mobility aid
- No contraindication for physical activity measured with the Physical Activity
Readiness Questionnaire (PAR-Q)

Exclusion Criteria

- Recurrence of HNC
- Secondary HNC
- HNC surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Physical performance, measured by the six minute walking test</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Muscle strength: measured by handgrip strength and microfet<br /><br>- Health related quality of life: measured by : the European Organisation for<br /><br>Research and Treatment for Cancer Quality of Life Questionnaire (EORTC<br /><br>QLQ-C30), the European Organisation for Research and Treatment for Cancer<br /><br>Quality of Life Questionnaire Head and Neck Module (EORTC-QLQ-HN43) and the<br /><br>EuroQol- Five Dimensions- Five Level (EQ-5D-5L)<br /><br>- Fatigue: measured by the Multidimensional Fatigue Inventory (MFI)<br /><br>- Body composition: measured by Body Mass Index (BMI)<br /><br>- Nutritional status: measured by the Short Nutritional Assessment<br /><br>Questionnaire (SNAQ)<br /><br>- Physical activity: measured by the Short Questionnaire to assess health<br /><br>enhancing physical activity (SQUASH)<br /><br>- Treatment tolerability<br /><br>- Health related costs: measured with Quality-Adjusted Life Year (QALY's) </p><br>