Physical Exercise for Patients With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— VITAL  

Official title:

The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988060
• Other study ID #: NL79549.028.21
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: November 9, 2026

Study information

• Verified date: August 2023
• Source: Institute Verbeeten
• Contact: Caroline Speksnijder, Dr.
• Phone: +3188758040
• Email: C.M.Speksnijder[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: November 9, 2026
• Est. primary completion date: November 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Experimental Intervention
Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology. Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.

Locations

Country	Name	City	State
Netherlands	Instituut Verbeeten	Tilburg	Noord Brabant

Sponsors (4)

Lead Sponsor	Collaborator
Institute Verbeeten	CZ Fonds, Stichting Fight Cancer, Verbeeten Fonds

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical performance	six minute walking test	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Muscle strength	Grip strength	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Muscle strength	30 seconds chair to stand test	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Muscle strength	Microfet handheld dynamometer	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Health Related Quality of Life	Assessed by the EuroQol- five dimensions- five level (EQ-5D-5L). This questionnaire contains 6 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a total score for global health. The first 5 item have 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score of these item can range from 0 to 4. The higher the total score of these five items, the lower the quality of live. The global health scores on a range 0-100. The higher the score of this item, the higher the global health.	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Health Related Quality of Life	Assessed by the European organisation for research and treatment for cancer quality of life questionnaire (EORTC QLQ-C30). This questionnaire contains 30 questions scoring 9 subscales and 6 single items: 5 functional scales, 3 symptom scales and 1 global health / quality of life scale. The score of each subscale of single items ranges from 0 to 100. A higher score on the functional scales means a high level of functioning. A higher score on the symptom scales means a high level of experiencing symptoms. A higher score on global health / quality of life means a high score of quality of life.	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Health Related Quality of Life	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.	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Fatigue	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.	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Body composition	body mass index (BMI)	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Nutrition status	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.	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Physical activity	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.	M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	Tolerability of radiotherapy, chemoradiation or bioradiation	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.	M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary	socio-demographic data and medical data	age, gender, education, employment, marital status tumour site, disease stage, comorbidity, HPV status, tobacco and alcohol use, nutrition status and type of treatment.	M0 (baseline/before (C/B)RT)