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Active Not Recruiting NA INTERVENTIONAL NCT05256238

Effect of Exercise in Head and Neck Cancer Patients

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: comprehensive supervised exercise program (CSEP)
Type: OTHER
Description: The CSEP starts as soon as possible after cancer diagnosis and lasts for 12 weeks: * week 1-6 (during cancer treatment): 2 supervised sessions at the exercise room of the University Hospital Leuven in connection to the radiotherapy treatment session and one additional session at home. Patients will receive equipment to perform the program at home, e.g. weights, therabands,… * week 7-12 (after cancer treatment): 1 supervised session at the exercise room of University Hospital Leuven in connection to the follow-up consultations (once a week) with the oncologist and two additional sessions at home * maintenance program (from week 13), patients will exercise at home with a monthly teleconsultation

Primary Outcomes

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.

Trial Information

NCT ID

NCT05256238

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Universitaire Ziekenhuizen KU Leuven

Last Updated

December 15, 2025