Physiotherapy Treatment for Patients Suffering From Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	Rigshospitalet, Denmark The Association of Danish Physiotherapists Research Fund, Denmark The Jubilee Fund of 1986, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00780312

Purpose

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.

Condition	Intervention	Phase
Cancer Cavi Oris Cancer Oropharynges Radiotherapy Trismus	Other: physiotherapy	Phase II

Genetics Home Reference related topics: lymphedema-distichiasis syndrome

MedlinePlus related topics: Cancer Head and Neck Cancer Lymphedema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Official Title:	Physiotherapy Versus no Physiotherapy to Patients Suffering From Head and Neck Cancer Undergoing Radiotherapy Treatment

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

The amplitude of mouth opening [ Time Frame: Fom baseline: day 1 or 2 of radiotherapy treatment to 12 month after completing radiotherapy treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tongue movement, range of motion of the cervical spine, lymphoedema, tightness of tissue, self estimated quality of life rating [ Time Frame: From baseline: day 1 or 2 of radiotherapy treatment to 12 months after completing radiotherapy treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: No Intervention 50 patients in this group get the existing hospital treatment: A 10 minute instruction in mouth opening exercises by a nurse before onset of radiotherapy treatment.
1: Experimental physiotherapy	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.

Arms

Assigned Interventions

2: No Intervention

50 patients in this group get the existing hospital treatment: A 10 minute instruction in mouth opening exercises by a nurse before onset of radiotherapy treatment.

1: Experimental

physiotherapy

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.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780312

Contacts

Contact: Lena Specht Specht, MD, DMSc	0045 35 45 39 69	lena.specht@rh.regionh.dk
Contact: Nina Høgdal	0045 35 45 22 08	nina.hoegdal@rh.regionh.dk

Locations

Denmark, Copenhagen Ø
Department of Occupational and Physical Therapy, 4114	Recruiting
Copenhagen, Copenhagen Ø, Denmark, 2100
Contact: Birgit Strange 0045 35 45 12 90 birgit.strange@rh.regionh.dk
Contact: Helle T Sørensen 0045 35 45 12 71 hts@rh.regionh.dk
Principal Investigator: Nina Høgdal

Sponsors and Collaborators

Rigshospitalet, Denmark

The Association of Danish Physiotherapists Research Fund, Denmark

The Jubilee Fund of 1986, Denmark

Investigators

Study Director:

Nina Høgdal

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

More Information

Responsible Party:	Department of Occupational and Physical Therapy, Copenhagen University Hospital, Rigshospitalet, Denmark ( Nina Høgdal, Physiotherapist, student of Master in Health Science at the University of Oslo, Norway )
Study ID Numbers:	H-KF-2006-6097
Study First Received:	October 24, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00780312
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:

radiotherapy
trismus
physiotherapy
lymphoedema

late side effects
fibrosis
decreased cervical range of motion
quality of life

Study placed in the following topic categories:

Spasm
Lymphedema
Signs and Symptoms
Fibrosis

Head and Neck Neoplasms
Quality of Life
Neurologic Manifestations
Trismus

Additional relevant MeSH terms:

Neuromuscular Manifestations
Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009