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Effect of Exercise in Head and Neck Cancer Patients

NCT05256238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

comprehensive supervised exercise program (CSEP)

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

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Sandra Nuyts, Prof · UZ/KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2025-06-23
Completion
2025-12-23

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05256238 on ClinicalTrials.gov