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Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment

I

Izmir Bakircay University

Status

Completed

Conditions

Fibrosis; Skin
Lymphedema of Face
Head and Neck Cancer

Treatments

Other: Complex decongestive physiotherapy
Other: Home program

Study type

Interventional

Funder types

Other

Identifiers

NCT04286698
2018-112

Details and patient eligibility

About

The aim of this study was to determine the effects of complex decongestive physiotherapy (CDP) and home programs on internal/external lymphedema, staging, fibrosis, and three-dimensional (3D) surface scanning and volume evaluation in head and neck lymphedema. Twenty-one patients were randomly divided into three groups: CDP; home program including self manual lymph drainage (MLD) and exercises; and control. CDP included MLD drainage, compression, exercise, and skin care. Self-MLD and exercises were performed by home program group patients. Assessment methods were applied at baseline and 4 weeks later for all groups. MD. Anderson Cancer Center Head and Neck Lymphedema Protocol was implemented to evaluate head and neck external lymphedema, staging, and fibrosis. An Artec Eva 3D scanner and the Autodesk ReCap Photo Studio software were used to determine and calculate the volume of the head and neck region via 3D surface scanning. Head and neck external lymphedema and fibrosis assessment criteria were performed to evaluate visible soft tissue edema and the degree of stiffness. To assess internal lymphedema, Patterson's scale was applied using fiber-optic endoscopic imaging.

Full description

Head and neck cancer (HNC) have been seen in 13.3/100,000 males and 2.8/100,000 in females in Turkey. HNC related treatments such as lymph node dissection, tumor excision, chemotherapy, radiotherapy, and cancer itself can cause head and neck lymphedema (HNL). The incidence of HNL due to HNC treatments (surgery, chemotherapy and chemoradiation) has been reported to be between 48% and 90%.

A recognition of HNL has been growing in recent years, but HNL is still much less recognized than upper and lower limb lymphedema and is easily ignored by both patients and health care providers. Therefore, in many cases, the diagnosis and treatment of HNL may be delayed, or patients cannot access treatment. In routine practice, after HNC, the self-absorption of HNL is generally expected. Clinical experiences have confirmed that HNL develops 2-6 months after cancer treatment and regresses in some patients over time.

A variety of physiotherapy approaches have been shown to prevent and minimize physical, functional, emotional, and social disorders resulting from HNL. However, complex decongestive physiotherapy (CDP) is considered a gold standard treatment method for lymphedema. This method consists of manual lymph drainage (MLD), skin care, compression therapy, and therapeutic exercises. Although there are many studies about the effects of CDP on upper and lower limbs, there is only a limited number of studies about HNL and CDP in the literature.

Enrollment

21 patients

Sex

All

Ages

22 to 73 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >18 years old
  • had unilateral/bilateral neck dissection
  • had received radiotherapy and/or chemotherapy
  • elapsed time of 3 or more months since cancer treatments
  • had secondary HNL

Exclusion criteria

  • having metastases due to HNC or other primary cancers
  • receiving/having received treatment to regulate the lymph flow
  • having the diagnosis of neurological, orthopedic, or rheumatologic diseases that may cause circulation and movement in the head and neck region.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

21 participants in 3 patient groups

Complex decongestive physiotherapy program group
Active Comparator group
Description:
Manuel lymph drainage, compression mask, exercises and skin care
Treatment:
Other: Complex decongestive physiotherapy
Home program group
Active Comparator group
Description:
Self-manuel lymph drainage and home exercises
Treatment:
Other: Home program
Control group
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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