Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| comprehensive supervised exercise program (CSEP) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- usual supportive care + comprehensive supervised exercise program (CSEP)
- interventionNames
- Other: comprehensive supervised exercise program (CSEP)
- type
- NO_INTERVENTION
- label
- usual supportive care
Primary outcomes (1)
- measure
- Health-related quality of life
- timeFrame
- 6 months post-diagnosis
- description
- Health-related quality of life will be measured with the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDVan Aperen K, Nuyts S, Devoogdt N, Troosters T, De Vrieze T, Gursen C, De Groef A. Cross-cultural adaptation, validity and reliability of the Dutch version of the Lymphedema Symptom Intensity and Distress Survey-Head and Neck version 2.0 (LSIDS-H&N v2.0) in head and neck cancer patients. Disabil Rehabil. 2026 Feb;48(4):1125-1140. doi: 10.1080/09638288.2025.2554945. Epub 2025 Sep 7. PMID 40914813
- DERIVEDVan Aperen K, De Groef A, Troosters T, Elshout P, Nuyts S. Feasibility of a comprehensive supervised exercise program during and after treatment of head and neck cancer: a mixed-methods study. Support Care Cancer. 2025 Jan 16;33(2):107. doi: 10.1007/s00520-024-09112-y. PMID 39820655
- DERIVEDVan Aperen K, De Groef A, Devoogdt N, De Vrieze T, Troosters T, Bollen H, Nuyts S. EffEx-HN trial: study protocol for a randomized controlled trial on the EFFectiveness and feasibility of a comprehensive supervised EXercise program during radiotherapy in Head and Neck cancer patients on health-related quality of life. Trials. 2023 Apr 15;24(1):276. doi: 10.1186/s13063-023-07170-x. PMID 37061715