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NCT Number: NCT05432297

Preventive Physical Activity Intervention in Head and Neck Cancer

The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location status: Recruiting

Location contact

Lisa Tuomi

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
  • Receiving radiohterapy (+/- chemotherapy) with curative intent

Exclusion criteria

  • Surgery due to head and neck cancer
  • Previous treatment for head and neck cancer
  • Tracheostomized patients
  • Inability to perform exercise intervention
  • Inability to perform part of 6-minute walking test
  • Inability to independently fill out questionnaires in Swedish
  • Previous neurologic or neuromuscular disease

Treatment and study plan

Preventive physical exercise

Behavioral

Daily physical activity depending on daily condition

Primary outcomes

  1. Objectively measured physical activity

    Time frame: Up to 12 months

    Measured with an accelerometer. Measures time spent in different activities i minutes/day.

  2. Subjectively measured physical activity - Saltin-Grimby

    Time frame: Up to 12 months

    Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.

  3. Subjectively measured physical activity (IPAQ)

    Time frame: Up to 12 months

    Measured with the International Physical Activity Questionnaire

Secondary outcomes

  1. Health related quality of life (HRQL) using the EORTC QLQ-C30

    Time frame: Up to 5 years post radiotherapy

    Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL.

  2. Health related quality of life (HRQL) using the EORTC QLQ H&N35

    Time frame: Up to 5 years post radiotherapy

    Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL.

  3. Trismus and jaw related symptoms

    Time frame: Up to 5 years post radiotherapy

    Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms.

  4. Dysphagia related symtoms

    Time frame: Up to 5 years post radiotherapy

    PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome.

  5. Maximal Interincisal opening (MIO)

    Time frame: Up to 5 years post radiotherapy

    Jaw opening measured in millimeters

  6. Body composition

    Time frame: Up to 12 months post radiotherapy

    Bioelectric impedance analysis.

  7. Grip strength

    Time frame: Up to 12 months post radiotherapy

    Measured with the a hand dynamometer

  8. 6-minute walking test

    Time frame: Up to 12 months post radiotherapy

    Measures total walking distance during 6 minutes.

Other outcomes

  1. Cost

    Time frame: Up to 5 years post radiotherapy

    The cost of intervention compared to usual care. Costs in Swedish crowns (SEK) for the intervention and all visits to healthcare during 5 years will be recorded.

  2. Quality of life for cost-effectiveness analysis

    Time frame: Up to 5 years post radiotherapy

    The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).

  3. Quality Adjusted Life Years (QALY)

    Time frame: Up to 5 years post radiotherapy

    QALY is a measurement that combines health-related quality of life (HRQL) and life expectancy in one index. The index range between 0 and 1, where 0 equals death and 1 represents perfect health. Thus, 1 QALY corresponds to 1 year of perfect health. This is calculated using the EQ-5D.

  4. Incremental Cost Effectiveness Ratio (ICER)

    Time frame: Up to 5 years post radiotherapy

    Incremental cost for each QALY for the intervention group will be calculated using a Markov model which combines the costs and EQ-5D. The ICER will then be compared to the maximum willingness to pay level which is SEK 500,000 (€55,000) according to the Swedish National Board of Health and Welfare.

Study contacts

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

Lisa Tuomi, PhD

CONTACT

[email protected]

+46313421000

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

Preventive Randomized Study Regarding Physical Activity Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Physical Activity, Function and Quality of Life

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
Jun 27, 2022
Registry last updated
Apr 23, 2026

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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