Effect of Exercise in Head and Neck Cancer Patients

NCT ID: NCT05256238

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2025-12-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

usual supportive care + comprehensive supervised exercise program (CSEP)

Group Type: EXPERIMENTAL

comprehensive supervised exercise program (CSEP)

Intervention Type: OTHER

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

usual supportive care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kom Op Tegen Kanker

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Nuyts, Prof

Role: PRINCIPAL_INVESTIGATOR

UZ/KU Leuven

Locations

University Hospital Leuven

Leuven, , Belgium

Countries

Belgium

References

Van 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. 2025 Sep 7:1-16. doi: 10.1080/09638288.2025.2554945. Online ahead of print.

Reference Type: DERIVED

PMID: 40914813 (View on PubMed)

Van 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.

Reference Type: DERIVED

PMID: 39820655 (View on PubMed)

Van 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.

Reference Type: DERIVED

PMID: 37061715 (View on PubMed)

Other Identifiers

s65549

Identifier Type: -

Identifier Source: org_study_id