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Trial Title:
Physical Exercise for Patients With Head and Neck Cancer
NCT ID:
NCT05988060
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
head and neck cancer
chemo- or bioradiotherapy
physical exercise intervention
physical performance
trial within cohorts
TwiCs
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Experimental Intervention
Description:
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.
Arm group label:
Patients who were randomized in the PEI group and accepted the invitation
Other name:
Physical Exercise Intervention
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituut Verbeeten
Address:
City:
Tilburg
Zip:
5042 SB
Country:
Netherlands
Status:
Recruiting
Start date:
November 9, 2022
Completion date:
November 9, 2026
Lead sponsor:
Agency:
Institute Verbeeten
Agency class:
Other
Collaborator:
Agency:
Verbeeten Fonds
Agency class:
Other
Collaborator:
Agency:
Stichting Fight Cancer
Agency class:
Other
Collaborator:
Agency:
CZ Fonds
Agency class:
Other
Source:
Institute Verbeeten
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05988060
