Oropharyngeal Cancer Clinical Trial
— HOHFOfficial title:
Physiotherapy Versus no Physiotherapy to Patients Suffering From Head and Neck Cancer Undergoing Radiotherapy Treatment
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Occupational and Physical Therapy, 8511 | Copenhagen | Copenhagen Ø |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | The Association of Danish Physiotherapists Research Fund, Denmark, The Jubilee Fund of 1986, Denmark |
Denmark,
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 |
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