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

Primary Purpose

Oral Cavity Carcinoma, Oropharyngeal Cancer, Adverse Effect of Radiation Therapy

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Cavity Carcinoma focused on measuring radiotherapy, trismus, physiotherapy, lymphoedema, late side effects, fibrosis, decreased cervical range of motion, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Occupational and Physical Therapy, 8511

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

2

1

Arm Description

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.

physiotherapy

Outcomes

Primary Outcome Measures

The amplitude of mouth opening
Maximum vertical dimension measured in millimetre using TheraBite "Range of Motion Scale"

Secondary Outcome Measures

Tongue movement
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
Measured by EDI-320 inclinometre
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
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
Self estimated quality of life rating. EORTC QLQ-C30 and QLQ-H&N35
Pain
By use of Visual Analogue Scale, measured in centimetre with one decimal

Full Information

First Posted
October 24, 2008
Last Updated
July 1, 2013
Sponsor
Rigshospitalet, Denmark
Collaborators
The Association of Danish Physiotherapists Research Fund, Denmark, The Jubilee Fund of 1986, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00780312
Brief Title
Physiotherapy Treatment for Patients Suffering From Head and Neck Cancer
Acronym
HOHF
Official Title
Physiotherapy Versus no Physiotherapy to Patients Suffering From Head and Neck Cancer Undergoing Radiotherapy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
The Association of Danish Physiotherapists Research Fund, Denmark, The Jubilee Fund of 1986, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Carcinoma, Oropharyngeal Cancer, Adverse Effect of Radiation Therapy, Trismus
Keywords
radiotherapy, trismus, physiotherapy, lymphoedema, late side effects, fibrosis, decreased cervical range of motion, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Arm Title
1
Arm Type
Experimental
Arm Description
physiotherapy
Intervention Type
Other
Intervention Name(s)
physiotherapy
Other Intervention Name(s)
Physiotherapy treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The amplitude of mouth opening
Description
Maximum vertical dimension measured in millimetre using TheraBite "Range of Motion Scale"
Time Frame
Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment
Secondary Outcome Measure Information:
Title
Tongue movement
Description
Questions asked to tongue movement using questionnaire from Kjaersgaard A, Coombes draft, 2005. Estimation possibility of choice: Normal, reduced, not able to
Time Frame
Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment
Title
Active range of motion of the cervical spine
Description
Measured by EDI-320 inclinometre
Time Frame
Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment
Title
Lymphoedema
Description
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
Time Frame
Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment
Title
Tightness of tissue
Description
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
Time Frame
Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment
Title
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
Title
Pain
Description
By use of Visual Analogue Scale, measured in centimetre with one decimal
Time Frame
Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Høgdal
Organizational Affiliation
Department of Occupational and Physical Therapy, Copenhagen University Hospital, Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Department of Occupational and Physical Therapy, 8511
City
Copenhagen
State/Province
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25229260
Citation
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.
Results Reference
derived

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Physiotherapy Treatment for Patients Suffering From Head and Neck Cancer

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