Effect of Exercise in Head and Neck Cancer Patients

NCT05256238 | Completed

• 1 other identifier: s65549
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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

Keywords

exercise program

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  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.

  6 months post-diagnosis

Secondary Outcomes (23)

• Health-related quality of life: physical functioning

  6 months

• Disease-specific health-related quality of life

  baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis

• Physical function: Pain

  baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis

• Physical function: Fatigue

  baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis

• Upper limb strength

  baseline- 6 weeks -12 weeks- 6 months - 12 months post-diagnosis

Other Outcomes (7)

• Feasibility of the CSEP: participation

  baseline

• Feasibility of the CSEP: compliance

  baseline, 12 weeks and/or 6 months

• Feasibility of the CSEP: sample characteristics

  baseline, 12 weeks and/or 6 months

Study Arms (2)

usual supportive care + comprehensive supervised exercise program (CSEP)

EXPERIMENTAL

Other: comprehensive supervised exercise program (CSEP)

usual supportive care

NO INTERVENTION

Interventions

comprehensive supervised exercise program (CSEP) 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 + comprehensive supervised exercise program (CSEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients \< 18 years
• ECOG ≥ 2
• Patient with HNC, treated with palliative intent
• Evidence of distant metastases

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Kom Op Tegen Kanker: collaborator

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (3)

• 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. 2026 Feb;48(4):1125-1140. doi: 10.1080/09638288.2025.2554945. Epub 2025 Sep 7.

  PMID: 40914813 DERIVED

• 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.

  PMID: 39820655 DERIVED

• 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.

  PMID: 37061715 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Sandra Nuyts, Prof

  UZ/KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: February 25, 2022
• Study Start: January 25, 2022
• Primary Completion: June 23, 2025
• Study Completion: December 23, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-01

Locations

BE (1)