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

February 25, 2020 updated by: Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06580
        • Kadirhan Ozdemir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Internal Lymphedema at 4 weeks
Time Frame: 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].
At baseline and 4 weeks later
Change from Baseline External Lymphedema at 4 weeks
Time Frame: 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].
At baseline and 4 weeks later
Change from Baseline Staging Lymphedema at 4 weeks
Time Frame: 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].
At baseline and 4 weeks later
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
Time Frame: 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].
At baseline and 4 weeks later
Change from Baseline 3D Surface Scanning and Volume Evaluation at 4 weeks
Time Frame: 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.
At baseline and 4 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Bakircay University

Collaborators

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

February 15, 2019

Study Completion (Actual)

March 15, 2019

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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