Preventive Physical Activity Intervention in Head and Neck Cancer

Sahlgrenska University Hospital80 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Head and Neck Neoplasms Physical Inactivity

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objectively measured physical activity

Measured with an accelerometer. Measures time spent in different activities i minutes/day.

Time frame: 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.

Time frame: Up to 12 months

Subjectively measured physical activity (IPAQ)

Measured with the International Physical Activity Questionnaire

Time frame: Up to 12 months

Secondary Outcomes

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.