Clinical trial NCT04286698: Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment
Official title: To Investigate the Effectiveness of Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lymphedema of Face
Fibrosis; Skin
Keywords: Complex decongestive physiotherapy
Home program
Manual lymph drainage
Face mask
3D analysis
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2020-02-27
Enrollment: 21
Sex: ALL
Minimum age (years): 22
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Internal Lymphedema at 4 weeks
timeFrame: At baseline and 4 weeks later
measure: Change from Baseline External Lymphedema at 4 weeks
timeFrame: At baseline and 4 weeks later
measure: Change from Baseline Staging Lymphedema at 4 weeks
timeFrame: At baseline and 4 weeks later
measure: Change from Baseline Characteristics of Tissue Changes (edema and/or fibrosis), The Anatomical Locations, and The Severity of The Identified Soft Tissue Abnormalities at 4 weeks
timeFrame: At baseline and 4 weeks later
measure: Change from Baseline 3D Surface Scanning and Volume Evaluation at 4 weeks
timeFrame: At baseline and 4 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kadirhan Ozdemir
Study officials:
References:
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