Physiotherapy Versus no Physiotherapy to Patients Suffering From Head and Neck Cancer Undergoing Radiotherapy Treatment
In Denmark there are about 1000 new cases of head and neck cancer every year. The number is
increasing. The treatment for head and neck cancer is either surgery or radiotherapy
treatment or a combination of these modalities. Radiotherapy treatment for head and neck
cancer often causes severe late term side effects.
Radiotherapy induced damage of the skin, lymphatic system, cartilage and bone often leads to
symptoms such as trismus, lymphoedema, decreased range of motion of the mouth, neck and
tongue, difficulty in using the mimic muscles, difficulty in swallowing and pain. The
severity of late side effects due to radiotherapy treatment for head and neck cancer often
leaves the patients with a poor quality of life rating.
Effects of physiotherapy interventions are scarcely investigated. Only few studies describe
the effect of physiotherapy treatment. The studies are difficult to compare because of
insufficiently described physiotherapy intervention, or variation of onset and extent of
physiotherapy intervention plus variation in study populations. No studies have described
the long term effects of physiotherapy intervention. There is no national or international
consensus for the physiotherapy treatment for patients undergoing treatment for head and
neck cancer.
Primary hypothesis:
Decreased mouth opening in patients suffering from c.cavi oris and c.oropharynges undergoing
radiotherapy treatment, can be reduced by an early physiotherapy effort compared with the
present circumstances.
Secondary hypothesis:
The extent of late side effects from radiotherapy treatment for head and neck cancer can be
reduced by an early and individually adjusted physiotherapy treatment.
Guided physiotherapy training/treatment can have a positive effect on patients self
estimated symptom extent and health related quality af life.
The hypothesis of this study is built on studies of literature and clinical experience from
treatment of late side effects on patients suffering from breast cancer and uterus cancer,
who also suffer from lymphoedema and fibrosis due to radiotherapy.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
The amplitude of mouth opening
Maximum vertical dimension measured in millimetre using TheraBite "Range of Motion Scale"
Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment
No
Nina Høgdal
Study Director
Department of Occupational and Physical Therapy, Copenhagen University Hospital, Rigshospitalet, Denmark
Denmark: The Danish National Committee on Biomedical Research Ethics
H-KF-2006-6097
NCT00780312
December 2008
March 2012
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