Clinical trial NCT05988060: Physical Exercise for Patients With Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
chemo- or bioradiotherapy
physical exercise intervention
physical performance
trial within cohorts
TwiCs
Lead sponsor: Institute Verbeeten
Sponsor class: OTHER
Collaborators: name: Verbeeten Fonds
name: Stichting Fight Cancer
name: CZ Fonds
First posted: 2023-08-14
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study a TwiCs design will be used. The TwiCs design consists of an experimental intervention study within an observational longitudinal cohort. This design uses a staged-informed consent. Patients will be asked to participate in an observational longitudinal cohort study and will be informed about the design with the probability to be randomly invited for an experimental intervention which they can accept or refuse. When patients are willing to participate in the observational longitudinal cohort, an informed consent (IC) will be signed. Directly after cohort enrollment, all patients will be randomized.
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility 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.

Primary outcomes:
measure: physical performance
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary outcomes:
measure: Muscle strength
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Muscle strength
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Muscle strength
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Health Related Quality of Life
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Health Related Quality of Life
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Health Related Quality of Life
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Fatigue
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Body composition
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Nutrition status
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Physical activity
timeFrame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: Tolerability of radiotherapy, chemoradiation or bioradiation
timeFrame: M1 (12 weeks), M2 (6 months), M3 (12 months)
measure: socio-demographic data and medical data
timeFrame: M0 (baseline/before (C/B)RT)
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Instituut Verbeeten
state: Noord Brabant
Study officials:
affiliation: Instituut Verbeeten
name: Yvette Kriellaars, Msc.
role: PRINCIPAL_INVESTIGATOR
References: