Physiotherapy Treatment for Patients Suffering From Head and Neck Cancer

NCT ID: NCT00780312

Last Updated: 2013-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-03-31

Brief 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.

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.

Conditions

Oral Cavity Carcinoma; Oropharyngeal Cancer; Adverse Effect of Radiation Therapy; Trismus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

2

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

1

physiotherapy

Group Type: EXPERIMENTAL

physiotherapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Physiotherapy treatment

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Association of Danish Physiotherapists Research Fund, Denmark

UNKNOWN

Sponsor Role: collaborator

The Jubilee Fund of 1986, Denmark

UNKNOWN

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Nina Høgdal

Role: STUDY_DIRECTOR

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

Locations

Department of Occupational and Physical Therapy, 8511

Copenhagen, Copenhagen Ø, Denmark

Countries

Denmark

References

Hogdal N, Juhl C, Aadahl M, Gluud C. Early preventive exercises versus usual care does not seem to reduce trismus in patients treated with radiotherapy for cancer in the oral cavity or oropharynx: a randomised clinical trial. Acta Oncol. 2015 Jan;54(1):80-7. doi: 10.3109/0284186X.2014.954677. Epub 2014 Sep 17.

Reference Type: DERIVED

PMID: 25229260 (View on PubMed)

Other Identifiers

H-KF-2006-6097

Identifier Type: -

Identifier Source: org_study_id