The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 112
- Locations
- 2
- Primary Endpoint
- physical performance
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
physical performance
Time Frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
six minute walking test
Secondary Outcomes
- Fatigue(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- socio-demographic data and medical data(M0 (baseline/before (C/B)RT))
- Nutrition status(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- Tolerability of radiotherapy, chemoradiation or bioradiation(M1 (12 weeks), M2 (6 months), M3 (12 months))
- Body composition(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- Physical activity(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- Muscle strength(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))
- Health Related Quality of Life(M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months))