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NCT Number: NCT05988060

Physical Exercise for Patients With Head and Neck Cancer

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).

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituut Verbeeten

Tilburg, North Brabant, 5042 SB, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • recurrence of HNC and/or
  • secondary HNC.

Treatment and study plan

Experimental Intervention

Other

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.

Other names: Physical Exercise Intervention

Primary outcomes

  1. physical performance

    Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

    six minute walking test

Secondary outcomes

  1. Muscle strength

    Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

    Grip strength

  2. Muscle strength

    Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

    30 seconds chair to stand test

  3. Muscle strength

    Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

    Microfet handheld dynamometer

  4. Health Related Quality of Life

    Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

    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.

  5. Health Related Quality of Life

    Time frame: 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 (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.

  6. Health Related Quality of Life

    Time frame: 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.

  7. Fatigue

    Time frame: 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.

  8. Body composition

    Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

    body mass index (BMI)

  9. Nutrition status

    Time frame: 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.

  10. Physical activity

    Time frame: 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.

  11. Tolerability of radiotherapy, chemoradiation or bioradiation

    Time frame: 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.

  12. socio-demographic data and medical data

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Speksnijder, Dr.

CONTACT

[email protected]

+3188758040

Jorine Vermaire, Dr.

CONTACT

[email protected]

+135947777

Sponsors and collaborators

Lead sponsor

Institute Verbeeten

Other

Collaborators

  • CZ Fonds
  • Stichting Fight Cancer
  • Verbeeten Fonds

Registry information

Official study 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

Acronym: VITAL

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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