Physical Exercise for Patients With Head and Neck Cancer

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Other: Experimental Intervention

• Registration Number: NCT05988060
• Lead Sponsor: Institute Verbeeten

Brief Summary

The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT).

Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.

Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-09
• Study First Submitted: 2023-07-20
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Primary Completion: 2025-11-09
• Study Completion: 2026-11-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. patients with HNC who are scheduled for (C/B)RT,
2. ≥18 years of age,
3. sufficient Dutch writing and reading skills,
4. a Karnofsky performance status (KPS) >60,
5. able to walk ≥60m without a mobility aid, and
6. no contraindication for physical activity as measured with the physical activity readiness questionnaire (PAR-Q).

Exclusion Criteria

1. recurrence of HNC and/or
2. secondary HNC.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients who were randomized in the PEI group and accepted the invitation	Experimental Intervention	The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.

Primary Outcome Measures

Name	Time	Method
physical performance	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)	six minute walking test

Secondary Outcome Measures

Name	Time	Method
Fatigue	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)	Assessed by the multidimensional fatigue inventory (MFI). The MFI contains 20 items scoring the following domains: general, physical and mental fatigue, and reduced activity and motivation. Every scale scores 4 till 20. The greater the score, the more fatigue or limitations in live because of fatigue.
Muscle strength	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)	Microfet handheld dynamometer
socio-demographic data and medical data	M0 (baseline/before (C/B)RT)	age, gender, education, employment, marital status tumour site, disease stage, comorbidity, HPV status, tobacco and alcohol use, nutrition status and type of treatment.
Health Related Quality of Life	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)	Assessed by the European organisation for research and treatment for cancer quality of life questionnaire head and neck module (EORTC-QLQ-H\&N43). This questionnaire contains 43 specific head and neck cancer questions scoring 19 subscales of symptoms. The higher the score of the subscale, the higher the level symptomology.
Nutrition status	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)	Assessed by the short nutritional assessment questionnaire (SNAQ). The short nutritional assessment questionnaire (SNAQ) consists of three questions and will be used to monitor nutritional status and assess the risk of malnutrition. The total score of this questionnaire ranges from 0 to 7. 0 means no nutritional problems and a high score means malnutrition.
Tolerability of radiotherapy, chemoradiation or bioradiation	M1 (12 weeks), M2 (6 months), M3 (12 months)	tolerability will be retrieved from medical records and registered as the percentage of scheduled treatment completion, percentage of (C/B)RT adjustment and type of (C/B)RT adjustment.
Body composition	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)	body mass index (BMI)
Physical activity	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)	Assessed by the short questionnaire to assess health enhancing physical activity (SQUASH). The SQUASH measures the frequency, duration and intensity of 4 different physical activity: physical activity going to work, physical activity during household activity, physical activity at work, physical activity in spare time. The higher the score, the higher the level of physical activity.

Trial Locations

Locations (1)

Instituut Verbeeten; 🇳🇱 Tilburg, Noord Brabant, Netherlands