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Physiotherapy Versus no Physiotherapy to Patients Suffering From Head and Neck Cancer Undergoing Radiotherapy Treatment


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer Cavi Oris, Cancer Oropharynges, Radiotherapy, Trismus

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Trial Information

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.


Inclusion Criteria:



- Patients with the clinical diagnosis of cancer cavi oris or cancer oropharynges
undergoing radiotherapy treatment

- Age > 18 years

- Informed consent

Exclusion Criteria:

- Patients who have had bone reconstruction surgery or grafting or where motor nerve
damage has occurred during surgery, inflicting the function of the neck or shoulder

- Patients suffering from a known musculoskeletal disease with symptoms that may
influence/disturb the picture of symptoms induced by radiotherapy to the
tempora-mandibular joint, the cervical spine, shoulders (e.g R.A, fibromyalgia,
arthritis,neurological disease, industrial injury)

- Patient with psychiatric diagnosis, who are unable to cooperate (including dementia)

- Patients whose general condition makes it impossible to attend the study (weak and
feeble)

- Patients who do not master the Danish language in a degree, that they can read and
understand written and verbal information

- The lack of informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

The amplitude of mouth opening

Outcome Description:

Maximum vertical dimension measured in millimetre using TheraBite "Range of Motion Scale"

Outcome Time Frame:

Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment

Safety Issue:

No

Principal Investigator

Nina H√łgdal

Investigator Role:

Study Director

Investigator Affiliation:

Department of Occupational and Physical Therapy, Copenhagen University Hospital, Rigshospitalet, Denmark

Authority:

Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:

H-KF-2006-6097

NCT ID:

NCT00780312

Start Date:

December 2008

Completion Date:

March 2012

Related Keywords:

  • Cancer Cavi Oris
  • Cancer Oropharynges
  • Radiotherapy
  • Trismus
  • radiotherapy
  • trismus
  • physiotherapy
  • lymphoedema
  • late side effects
  • fibrosis
  • decreased cervical range of motion
  • quality of life
  • Head and Neck Neoplasms
  • Trismus
  • Stress, Psychological

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