Physiotherapy Treatment for Patients Suffering From Head and Neck Cancer (HOHF)

This study has been completed.
Sponsor:
Collaborators:
The Association of Danish Physiotherapists Research Fund, Denmark
The Jubilee Fund of 1986, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00780312
First received: October 24, 2008
Last updated: July 1, 2013
Last verified: July 2012
  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
Oral Cavity Carcinoma
Oropharyngeal Cancer
Adverse Effect of Radiation Therapy
Trismus
Other: physiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Physiotherapy Versus no Physiotherapy to Patients Suffering From Head and Neck Cancer Undergoing Radiotherapy Treatment

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • The amplitude of mouth opening [ Time Frame: Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment ] [ Designated as safety issue: No ]
    Maximum vertical dimension measured in millimetre using TheraBite "Range of Motion Scale"


Secondary Outcome Measures:
  • Tongue movement [ Time Frame: Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment ] [ Designated as safety issue: No ]
    Questions asked to tongue movement using questionnaire from Kjaersgaard A, Coombes draft, 2005. Estimation possibility of choice: Normal, reduced, not able to

  • Active range of motion of the cervical spine [ Time Frame: Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment ] [ Designated as safety issue: No ]
    Measured by EDI-320 inclinometre

  • Lymphoedema [ Time Frame: Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment ] [ Designated as safety issue: No ]
    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

  • Tightness of tissue [ Time Frame: Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment ] [ Designated as safety issue: No ]
    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

  • Self estimated quality of life rating. EORTC QLQ-C30 and QLQ-H&N35 [ Time Frame: Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment ] [ Designated as safety issue: No ]
    By use of Visual Analogue Scale, measured in centimetre with one decimal


Enrollment: 97
Study Start Date: December 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 1
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.
Other Name: Physiotherapy 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Department of Occupational and Physical Therapy, 8511
Copenhagen, Copenhagen Ø, Denmark, 2100
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

No publications provided

Responsible Party: Nina Høgdal, Physiotherapist, student of Master in Health Science at the University of Oslo, Norway, Department of Occupational and Physical Therapy, Copenhagen University Hospital, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00780312     History of Changes
Other Study ID Numbers: H-KF-2006-6097
Study First Received: October 24, 2008
Last Updated: July 1, 2013
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

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Trismus
Oropharyngeal Neoplasms
Stress, Psychological
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 25, 2014