NCT05256238Completed
Effect of Exercise in Head and Neck Cancer Patients
Improving Health-related Quality of Life of Head and Neck Cancer Patients Via a Dedicated Comprehensive Supervised Exercise Program (CSEP)
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 133 (actual)
- First submitted
- 23 Nov 2021
- Start date
- 25 Jan 2022
- Primary completion date
- 23 Jun 2025
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Head and neck cancer
- NCT number
- NCT05256238
What you commit to
- Study type: Interventional
- Participants enrolled: 133
- From 25 Jan 2022 to the primary completion date, 23 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with HNC, treated with palliative intent
Age
- Patients \< 18 years
Other
- ECOG ≥ 2
- Evidence of distant metastases
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.