Clinical trial NCT05432297: Preventive Physical Activity Intervention in Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Physical Inactivity
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Objectively measured physical activity
timeFrame: Up to 12 months
measure: Subjectively measured physical activity - Saltin-Grimby
timeFrame: Up to 12 months
measure: Subjectively measured physical activity (IPAQ)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Health related quality of life (HRQL) using the EORTC QLQ-C30
timeFrame: Up to 5 years post radiotherapy
measure: Health related quality of life (HRQL) using the EORTC QLQ H&N35
timeFrame: Up to 5 years post radiotherapy
measure: Trismus and jaw related symptoms
timeFrame: Up to 5 years post radiotherapy
measure: Dysphagia related symtoms
timeFrame: Up to 5 years post radiotherapy
measure: Maximal Interincisal opening (MIO)
timeFrame: Up to 5 years post radiotherapy
measure: Body composition
timeFrame: Up to 12 months post radiotherapy
measure: Grip strength
timeFrame: Up to 12 months post radiotherapy
measure: 6-minute walking test
timeFrame: Up to 12 months post radiotherapy
Other outcomes:
measure: Cost
timeFrame: Up to 5 years post radiotherapy
measure: Quality of life for cost-effectiveness analysis
timeFrame: Up to 5 years post radiotherapy
measure: Quality Adjusted Life Years (QALY)
timeFrame: Up to 5 years post radiotherapy
measure: Incremental Cost Effectiveness Ratio (ICER)
timeFrame: Up to 5 years post radiotherapy
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Lisa Tuomi, PhD
role: PRINCIPAL_INVESTIGATOR
References: