RecruitingNot ApplicableNCT05988060

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


Sponsor

Institute Verbeeten

Enrollment

112 participants

Start Date

Nov 9, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria2

  • recurrence of HNC and/or
  • secondary HNC.

Interventions

OTHERExperimental Intervention

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.


Locations(1)

Instituut Verbeeten

Tilburg, North Brabant, Netherlands

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NCT05988060


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