Preventive Physical Activity Intervention in Head and Neck Cancer

NCT05432297 | Recruiting

• 1 other identifier: 01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Neoplasms; Physical Inactivity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

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

  Up to 5 years post radiotherapy

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

  Up to 5 years post radiotherapy

• Trismus and jaw related symptoms

  Up to 5 years post radiotherapy

• Dysphagia related symtoms

  Up to 5 years post radiotherapy

• Maximal Interincisal opening (MIO)

  Up to 5 years post radiotherapy

Other Outcomes (4)

• Cost

  Up to 5 years post radiotherapy

• Quality of life for cost-effectiveness analysis

  Up to 5 years post radiotherapy

• Quality Adjusted Life Years (QALY)

  Up to 5 years post radiotherapy

Study Arms (2)

Physical exercise intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.

Interventions

Preventive physical exercise BEHAVIORAL

Daily physical activity depending on daily condition

Physical exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Sedentary Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Behavior

Study Officials

• Lisa Tuomi, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Tuomi, PhD

CONTACT

+46313421000; tuomi.lisa@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: June 27, 2022
• Study Start: January 2, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

SE (1)