Preventive Physical Activity Intervention in Head and Neck Cancer

Sahlgrenska University Hospital

Status: Enrolling

Conditions: Physical Inactivity; Head and Neck Neoplasms

Treatments: Behavioral: Preventive physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05432297

01

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Physical exercise intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Preventive physical exercise

Control

No Intervention group

Description:

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