Clinical trial NCT05256238: Effect of Exercise in Head and Neck Cancer Patients
Official title: Improving Health-related Quality of Life of Head and Neck Cancer Patients Via a Dedicated Comprehensive Supervised Exercise Program (CSEP)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: exercise program
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
First posted: 2022-02-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Head and neck cancers (HNC) are malignancies originating from the mucosa in the oral cavity, nasopharynx, oropharynx, hypopharynx and larynx. Unfortunately, the majority of patients with HNC have locally advanced disease at diagnosis and should, therefore, be treated with chemoradiotherapy (CRT) or with radical surgery followed by adjuvant (C)RT. Treatment of HNCs with (C)RT frequently results in serious and persistent impairments in physical and psychosocial functioning. In order to prevent worsening of a person's functioning at diagnoses and limit the physical impact of the treatments for HNC, a comprehensive supervised exercise program (CSEP) is needed early during treatment.

There is a need to improve integration of exercise programs into HNC care with aim to help head and neck cancer patients regain physical, mental and social functioning. Currently, no program is available adapted to the specific needs of head and neck cancer patients, in particular during cancer treatment.

The primary scientific objective is to examine the effectiveness of a comprehensive supervised exercise program, in addition to usual care, on health-related quality of life (primary outcome parameters) during treatment of head and neck cancer, compared to usual care only, up to 1 year after diagnosis.

Secondary objectives entail gathering information on the effectiveness of the CSEP, in addition to usual care on secondary outcome parameter such as physical and mental functioning, activity level and participation level; to determine the feasibility of such CSEP (defined as at least 50% of eligible patients enrolling in the study and completing at least 50% of the planned intervention sessions) and possible barriers and facilitators for participating in a CSEP during head and neck cancer treatment.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years
* Diagnosed with primary malignant tumour head and neck region (oral cavity, nasal cavity and paranasal sinuses, pharynx, larynx, salivary glands, thyroid)
* ECOG performance score 0-1
* Planned for curative (chemo)radiotherapy
* Able to complete baseline assessments prior to start of radiotherapy.
* Physically and mentally capable of taking part in an exercise program and motivated to engage in a supervised exercise program.

Exclusion Criteria:

* Patients \< 18 years
* ECOG ≥ 2
* Patient with HNC, treated with palliative intent
* Evidence of distant metastases

Primary outcomes:
measure: Health-related quality of life
timeFrame: 6 months post-diagnosis
Secondary outcomes:
measure: Health-related quality of life: physical functioning
timeFrame: 6 months
measure: Disease-specific health-related quality of life
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Physical function: Pain
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Physical function: Fatigue
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Upper limb strength
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Lymphedema: neck circumference measurement
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Lymphedema: %water content
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Lymphedema: self-reported
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Shoulder forward flexion and abduction range of motion
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Physical fitness
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Body composition: amount of fat, bone, water, and muscle in the body
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Physical functioning
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Radiotherapy-related fibrosis
timeFrame: baseline- 6 weeks -12 weeks
measure: Radiotherapy-related fibrosis
timeFrame: 6 months - 12 months
measure: Depression, anxiety, stress
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Self-efficacy
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Stage of readiness to change
timeFrame: baseline -12 weeks
measure: Motivation towards exercise
timeFrame: baseline -12 weeks
measure: Upper limb function
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Physical activity level
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Social participation
timeFrame: baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Return to work
timeFrame: baseline - 6 weeks -12 weeks- 6 months - 12 months post-diagnosis
measure: Health-related quality of life
timeFrame: baseline - 6 weeks -12 weeks- 12 months post-diagnosis
Other outcomes:
measure: Feasibility of the CSEP: participation
timeFrame: baseline
measure: Feasibility of the CSEP: compliance
timeFrame: baseline, 12 weeks and/or 6 months
measure: Feasibility of the CSEP: sample characteristics
timeFrame: baseline, 12 weeks and/or 6 months
measure: Feasibility of the CSEP: retention of participants
timeFrame: 6 months
measure: Feasibility of the CSEP: satisfaction
timeFrame: 12 weeks and 6 months
measure: safety: reported health risks associated with the CSEP
timeFrame: baseline, 12 weeks and/or 6 months
measure: Feasibility of the CSEP in daily clinical practice
timeFrame: baseline, 12 weeks and/or 6 months
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: UZ/KU Leuven
name: Sandra Nuyts, Prof
role: PRINCIPAL_INVESTIGATOR
References: