Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment
- Conditions
- Head and Neck CancerFibrosis; SkinLymphedema of Face
- Interventions
- Other: Complex decongestive physiotherapyOther: Home program
- Registration Number
- NCT04286698
- Lead Sponsor
- Izmir Bakircay University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- >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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Complex decongestive physiotherapy program group Complex decongestive physiotherapy Manuel lymph drainage, compression mask, exercises and skin care Home program group Home program Self-manuel lymph drainage and home exercises
- Primary Outcome Measures
Name Time Method Change from Baseline Internal Lymphedema at 4 weeks At baseline and 4 weeks later Patterson's scale is the most comprehensive scale for evaluating internal HNL. It is a fiber-optic endoscopic imaging method applied by an otolaryngologist to assess the gaps in the pharynx and larynx with regard to edema. Also, 11 different structures (base of tongue, posterior pharyngeal wall, epiglottis, pharyngoepiglottic folds, aryepiglottic folds, interarytenoid space, cricopharyngeal prominence, arytenoids, false vocal folds, true vocal folds, anterior commissure) and two spaces (vallecula and pyriform sinus) are rated as normal, mild, moderate, or severe during the inspection \[26\].
Change from Baseline External Lymphedema at 4 weeks At baseline and 4 weeks later The MD Anderson Cancer Center HNL standard evaluation protocol includes two facial circumference measurements and nine point-to-point tape measurements between the reference points on the face \[27\].
Seven key facial measurements were totaled to form a composite facial score. In addition, composite neck score was obtained by performing circumference measurements from three different regions of the neck \[27\].
In order to clinically determine the development of external HNL, a reduction in the lymphedema stage or a minimum 2% reduction was required in absolute values in composite measurements that were equivalent to a change of at least 2 cm \[2, 28\].Change from Baseline 3D Surface Scanning and Volume Evaluation at 4 weeks At baseline and 4 weeks later This evaluation was applied with an Artec Eva 3D scanner. The measurements and analyses were performed for seven different anatomical reference points. Seven markers were used to facilitate the calculation of the volume of the face and neck following the 3D scanning of the face and neck area; the data obtained were transferred to computer. After the scan was completed, a pattern atlas was created using the Autodesk ReCap photo software for the data on image, geometry, and texture. Finally, the predetermined reference points were combined, and the volume of the remaining portion was calculated by the volume of the 3D network representing the scanned geometry. In addition, the properties of the object were calculated using MESHLAB software.
Change from Baseline Staging Lymphedema at 4 weeks At baseline and 4 weeks later The MD Anderson Cancer Center HNL rating scale was based on the traditional Földi's scale, which is used for staging limb lymphedema and determining the severity \[3\]. The only difference between the MD Anderson Cancer Center HNL rating scale and Földi's scale is that Stage 1 is divided into Stage 1a and Stage 1b on Földi's scale. Stage 0 demonstrates lymphedema without visible edema but with a complaint of tissue heaviness. Stage 1a represents soft visible edema without pitting and which is reversible. Stage 1b shows soft pitting edema, which remains reversible. Stage 2 displays firm pitting edema, which is irreversible but lacks tissue changes. Stage 3 lymphedema, the most severe of all stages, represents irreversible tissue changes such as hyperkeratosis or papillomatosis \[27\].
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 At baseline and 4 weeks later The HNC related external lymphedema and fibrosis assessment criteria were used to evaluate the parameters, including the presence of visible soft tissue edema, the degree of stiffness of the tissues involved, and the severity of the lymphedema on the left periorbital region, right periorbital region, left cheek, right cheek, and submental region. This scale was used for rating the tissue under four headings for each region: Type A, Type B, Type C, and Type D. Next, each type other than Type A was graded as mild, moderate, and severe \[29\].
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kadirhan Ozdemir
🇹🇷Ankara, Turkey