Physiotherapy Treatment for Patients Suffering From Head and Neck Cancer

Oropharyngeal Cancer Clinical Trial

— HOHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780312
• Other study ID #: H-KF-2006-6097
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2008
• Last updated: July 1, 2013
• Start date: December 2008
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether the extent of late sequelae symptoms(reduced mouth opening, lymphoedema, decreased range of motion in the neck and shoulder region, speech and swallow disorders and reduced facial expression) due to radiotherapy treatment for head and neck cancer can be reduced by an individually adjusted physiotherapy effort applied immediately after the onset of and during radiotherapy treatment.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adverse Effect of Radiation Therapy
• Head and Neck Neoplasms
• Oral Cavity Carcinoma
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Trismus

Intervention

Other:
• physiotherapy
50 patients in this group get the existing hospital treatment: A 10 minute instruction in mouth opening exercises by a nurse. Furthermore they receive in all 6-7 sessions of physiotherapy treatment for a 5-6 weeks period with sessions of approximately 45 minutes. 2 months after having completed radiotherapy treatment they receive a final physiotherapy treatment. The treatment consists of instruction in active and passive exercises for mouth opening, stretching exercises for the neck and shoulder region, tongue exercises, mimic exercises, self administered lymph drainage and softening of fibrotic tissue.

Locations

Country	Name	City	State
Denmark	Department of Occupational and Physical Therapy, 8511	Copenhagen	Copenhagen Ø

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Association of Danish Physiotherapists Research Fund, Denmark, The Jubilee Fund of 1986, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Tongue movement	Questions asked to tongue movement using questionnaire from Kjaersgaard A, Coombes draft, 2005. Estimation possibility of choice: Normal, reduced, not able to	Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment	No
Secondary	Active range of motion of the cervical spine	Measured by EDI-320 inclinometre	Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment	No
Secondary	Lymphoedema	Measusers of distance by tape measure in centimetre with one decimal between: incisura intertragica and protuberantia mentalis dexter and sinister, incisura intertragica and angulus oris dexter and sinister, incisura intertragica dexter and sinister under chin and neck circumference measured horizontal in line with the centre of larynx	Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment	No
Secondary	Tightness of tissue	Questions asked to function of opening mouth, tongue movement, neck movement If yes, How difficult is it for you to open your mouth, move your tongue, move your neck (possibility of choice: not at all, very little,a bit, quite difficult, very difficult).The feeling of tightness: Does your skin and/or muscle in the face/throat/neck area feel tight? If yes, the feeling of tightness is estimated by use of Visual Analogue Scale measured in centimetre with one decimal	Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment	No
Secondary	Self estimated quality of life rating. EORTC QLQ-C30 and QLQ-H&N35		Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment	No
Secondary	Pain	By use of Visual Analogue Scale, measured in centimetre with one decimal	Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment	No