Physiotherapy Treatment for Patients Suffering From Head and Neck Cancer

NCT00780312 | Completed Phase 2 DMC

• 1 other identifier: H-KF-2006-6097
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Tongue movement

  Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment

• Active range of motion of the cervical spine

  Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment

• Lymphoedema

  Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment

• Tightness of tissue

  Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment

• 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

Study Arms (2)

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

Interventions

physiotherapy 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.

Also known as: Physiotherapy treatment

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the clinical diagnosis of cancer cavi oris or cancer oropharynges undergoing radiotherapy treatment
• Age \> 18 years
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Association of Danish Physiotherapists Research Fund, Denmark: collaborator
• The Jubilee Fund of 1986, Denmark: collaborator

Study Sites (1)

Department of Occupational and Physical Therapy, 8511

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 25229260 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms; Radiation Injuries; Trismus; Lymphedema; Fibrosis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Nina Høgdal

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 27, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 2, 2013

Record last verified: 2012-07

Locations

DK (1)