Preventive Physical Activity Intervention in Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preventive physical exercise.
- Who it may be relevant to
- Registry conditions: Head and Neck Neoplasms, Physical Inactivity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
Interventions
- Behavioral Preventive physical exercise
Daily physical activity depending on daily condition
Primary outcome measures
- Objectively measured physical activity [Time frame: Up to 12 months]
- Subjectively measured physical activity - Saltin-Grimby [Time frame: Up to 12 months]
- Subjectively measured physical activity (IPAQ) [Time frame: Up to 12 months]
Secondary outcome measures (8)
- Health related quality of life (HRQL) using the EORTC QLQ-C30 [Time frame: Up to 5 years post radiotherapy]
- Health related quality of life (HRQL) using the EORTC QLQ H&N35 [Time frame: Up to 5 years post radiotherapy]
- Trismus and jaw related symptoms [Time frame: Up to 5 years post radiotherapy]
- Dysphagia related symtoms [Time frame: Up to 5 years post radiotherapy]
- Maximal Interincisal opening (MIO) [Time frame: Up to 5 years post radiotherapy]
- Body composition [Time frame: Up to 12 months post radiotherapy]
- Grip strength [Time frame: Up to 12 months post radiotherapy]
- 6-minute walking test [Time frame: Up to 12 months post radiotherapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Sweden · 1 center
- Sahlgrenska University Hospital — Gothenburg
Identifiers
NCT: NCT05432297 · 01