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

Head and Neck Cancer Clinical Trial

Official title:

To Investigate the Effectiveness of Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286698
• Other study ID #: 2018-112
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: February 2020
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 73 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis; Skin
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphedema
• Lymphedema of Face

Intervention

Other:
• Complex decongestive physiotherapy
MLD was administered 5 days a week for 4 weeks, with each session lasting 30 minutes [25]. Compression therapy was applied to the patients by wearing a compression mask (FM Velcro Fastener, LIPOELASTIC), made of polyamide, cotton, viscose, and elastane, that covered the submandibular region, the masseter region, and the neck. The compression mask is specifically designed for the healing and recovery of tissues after plastic and aesthetic surgeries. The patients were advised to wear the compression masks for at least 4-6 hours per day for 4 weeks and gradually increase wearing time according to their tolerance. The patients were asked to perform skin care by themselves. Skin care was applied using a low pH skin lotion to moisturize the skin. Neck, face/mimic, tongue, and posture exercises were performed by patients while the compression mask was worn and under the supervision of a physiotherapist, with 10 repetitions 5 times a week for 4 weeks.
• Home program
Self-MLD and exercises (neck, face/mimic, tongue, and posture exercises) were shown to the patients in this group. Self-MLD included self-administered lymph drainage of the axillary, posterior, lateral, and anterior neck areas; the pre- and retro-auricular regions; the lateral and anterior regions of the face; and the lower jaw region. Then the order is reversed back to the starting point [3]. A video of self-MLD and a text including exercise descriptions were shared with patients and their relatives to ensure that the self-MLD and exercises were performed accurately and regularly at home. Self-MLD was recommended to be applied once a day, and the exercises were advised to be performed for 10 repetitions each, 10 times a day for 4 weeks. The patients were called by phone during the second week after their first evaluation as a control and to motivate the patient for performing self-MLD and home exercises properly.

Locations

Country	Name	City	State
Turkey	Kadirhan Ozdemir	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Bakircay University	Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Crane P, Feinberg L, Morris J. A multimodal physical therapy approach to the management of a patient with temporomandibular dysfunction and head and neck lymphedema: a case report. J Man Manip Ther. 2015 Feb;23(1):37-42. doi: 10.1179/2042618612Y.0000000021. — View Citation

Della Justina, L.B. and M. Dias, Head and neck lymphedema: what is the physical therapy approach? A literature review. Fisioterapia em Movimento, 2016. 29(2): p. 411-419.

Deng J, Ridner SH, Dietrich MS, Wells N, Wallston KA, Sinard RJ, Cmelak AJ, Murphy BA. Prevalence of secondary lymphedema in patients with head and neck cancer. J Pain Symptom Manage. 2012 Feb;43(2):244-52. doi: 10.1016/j.jpainsymman.2011.03.019. Epub 2011 Jul 30. — View Citation

Deng J, Ridner SH, Murphy BA. Lymphedema in patients with head and neck cancer. Oncol Nurs Forum. 2011 Jan;38(1):E1-E10. doi: 10.1188/11.ONF.E1-E10. Review. — View Citation

Doke KN, Bowman L, Shnayder Y, Shen X, TenNapel M, Thomas SM, Neupane P, Yeh HW, Lominska CE. Quantitative clinical outcomes of therapy for head and neck lymphedema. Adv Radiat Oncol. 2018 Apr 27;3(3):366-371. doi: 10.1016/j.adro.2018.04.007. eCollection 2018 Jul-Sep. — View Citation

Piso DU, Eckardt A, Liebermann A, Gutenbrunner C, Schäfer P, Gehrke A. Early rehabilitation of head-neck edema after curative surgery for orofacial tumors. Am J Phys Med Rehabil. 2001 Apr;80(4):261-9. — View Citation

Ridner SH. Pathophysiology of lymphedema. Semin Oncol Nurs. 2013 Feb;29(1):4-11. doi: 10.1016/j.soncn.2012.11.002. Review. — View Citation

Smile TD, Tendulkar R, Schwarz G, Arthur D, Grobmyer S, Valente S, Vicini F, Shah C. A Review of Treatment for Breast Cancer-Related Lymphedema: Paradigms for Clinical Practice. Am J Clin Oncol. 2018 Feb;41(2):178-190. doi: 10.1097/COC.0000000000000355. — View Citation

Smith BG, Hutcheson KA, Little LG, Skoracki RJ, Rosenthal DI, Lai SY, Lewin JS. Lymphedema outcomes in patients with head and neck cancer. Otolaryngol Head Neck Surg. 2015 Feb;152(2):284-291. doi: 10.1177/0194599814558402. Epub 2014 Nov 11. — View Citation

Watanabe Y, Koshiyama M, Seki K, Nakagawa M, Ikuta E, Oowaki M, Sakamoto SI. Development and Themes of Diagnostic and Treatment Procedures for Secondary Leg Lymphedema in Patients with Gynecologic Cancers. Healthcare (Basel). 2019 Aug 27;7(3). pii: E101. doi: 10.3390/healthcare7030101. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Internal Lymphedema at 4 weeks	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].	At baseline and 4 weeks later
Primary	Change from Baseline External Lymphedema at 4 weeks	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].	At baseline and 4 weeks later
Primary	Change from Baseline Staging Lymphedema at 4 weeks	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].	At baseline and 4 weeks later
Primary	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	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].	At baseline and 4 weeks later
Primary	Change from Baseline 3D Surface Scanning and Volume Evaluation at 4 weeks	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.	At baseline and 4 weeks later