Preventive Physical Activity Intervention in Head and Neck Cancer

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

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Neoplasms; Physical Inactivity
• Intervention / Treatment: Behavioral: Preventive physical exercise

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Tuomi, PhD; Phone Number: +46313421000; Email: tuomi.lisa@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Lisa Tuomi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical exercise intervention; The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated.	Behavioral: Preventive physical exercise; Daily physical activity depending on daily condition
No Intervention: Control; The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objectively measured physical activity	Measured with an accelerometer. Measures time spent in different activities i minutes/day.	Up to 12 months
Subjectively measured physical activity - Saltin-Grimby	Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.	Up to 12 months
Subjectively measured physical activity (IPAQ)	Measured with the International Physical Activity Questionnaire	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trismus and jaw related symptoms	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.	Up to 5 years post radiotherapy
Dysphagia related symtoms	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.	Up to 5 years post radiotherapy
Maximal Interincisal opening (MIO)	Jaw opening measured in millimeters	Up to 5 years post radiotherapy
Health related quality of life (HRQL) using the EORTC QLQ-C30	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.	Up to 5 years post radiotherapy
Health related quality of life (HRQL) using the EORTC QLQ H&N35	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.	Up to 5 years post radiotherapy
Body composition	Bioelectric impedance analysis.	Up to 12 months post radiotherapy
Grip strength	Measured with the a hand dynamometer	Up to 12 months post radiotherapy
6-minute walking test	Measures total walking distance during 6 minutes.	Up to 12 months post radiotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost	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.	Up to 5 years post radiotherapy
Quality of life for cost-effectiveness analysis	The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).	Up to 5 years post radiotherapy
Quality Adjusted Life Years (QALY)	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.	Up to 5 years post radiotherapy
Incremental Cost Effectiveness Ratio (ICER)	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.	Up to 5 years post radiotherapy

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Investigators: Principal Investigator: Lisa Tuomi, PhD, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Behavior; Head and Neck Neoplasms; Sedentary Behavior
• Other Study ID Numbers: 01 (Miami VAHS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No