Head and neck lymphedema management: Evaluation of a therapy program

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1 Received: 21 February 2017 Revised: 2 June 2017 Accepted: 20 December 2017 DOI: /hed ORIGINAL ARTICLE Head and neck lymphedema management: Evaluation of a therapy program Amanda Pigott BOccThy, PhD 1 Jodie Nixon BAppSc (OccThy) 1 Jennifer Fleming BOccThy, PhD 2 Sandro Porceddu MD, FRANZCR 3 1 Occupational Therapy Department, Princess Alexandra Hospital, Brisbane, Australia 2 The School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia 3 Radiation Oncology Department, Princess Alexandra Hospital, University of Queensland, Brisbane, Australia Correspondence Amanda Pigott, Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Rd, Woolloongabba 4102, Australia. amanda.pigott@health.qld.gov.au Abstract Background: The purpose of this pilot study was to examine a therapeutic intervention for head and neck lymphedema. The 22-week intervention involved therapist-led care and participant self-management. Effectiveness was evaluated using a previously described lymphedema assessment tool, the Assessment of Lymphedema of the Head and Neck (ALOHA) to detect change over the course of the 22 weeks of treatment, and before and after a single treatment session. Methods: A prospective observational pilot study was conducted with a cohort of 10 participants assessed. Measurements of size (tape measurements) and water content (tissue dielectric constant [TDC]) were used, per the ALOHA protocol. Participants received 13 lymphedema therapy treatments at reducing frequencies over 22 weeks and daily self-management. Results: There was an overall significant reduction in lower neck circumference (F [2.15,19.35] ; P 5.004), upper neck circumference (F [5,45] ; P <.001) and TDC (F (5,45) ; P <.001) over time. There were no significant differences over the course of treatment for mean ear-to-ear measurements or before and after a single session of treatment. Conclusion: This pilot study found a reduction in head and neck lymphedema over the 22-week lymphedema treatment course. This intervention may be successful in reducing head and neck lymphedema; however, further studies are needed to investigate these findings in a larger sample with the use of a control group to negate improvements from healing over time. KEYWORDS head, lymphedema, neck, therapy, treatment 1 INTRODUCTION Most people undergoing head and neck cancer treatment may experience head and neck lymphedema. Previous research has reported head and neck lymphedema rates from over 75% 1 to 90% 2 in this group. Despite this large prevalence, head and neck lymphedema continues to be reported as an underrecognized and undertreated condition. 2,3 People with head and neck lymphedema experience more frequent and intense distress from altered sensation, more frequent and severe pain, and more functional deficits, such as swallowing and breathing problems, than similar patients without head and neck lymphedema. 4 In addition to physical symptoms, people with head and neck lymphedema also experience psychosocial concerns, particularly relating to their altered appearance. 5 The need for effective head and neck lymphedema symptom resolution in this population is clear. Head & Neck. 2018;40: wileyonlinelibrary.com/journal/hed VC 2018 Wiley Periodicals, Inc. 1131

2 1132 PIGOTT ET AL. Head and neck lymphedema is distinctly different to lymphedema that occurs in other sites of the body and requires a customized approach for its assessment and treatment. 6 There has been scarce examination of the effectiveness of head and neck lymphedema treatment, in part, due to its underrecognition, but also due to the lack of an effective assessment to evaluate the condition and its treatment. 7,8 This research group has previously developed an assessment for external head and neck lymphedema, the Assessment of Lymphedema of the Head and Neck (ALOHA). 9 The ALOHA focuses on the measurement of the neck and submental region, as these have been identified as the most common locations for external head and neck lymphedema. 6,10 The ALOHA measures include tape measurement points and the tissue dielectric constant (TDC), assessed using the MoistureMeter D (Delfin Technologies, Kuopio, Finland). The ALOHA has undergone previous validity and reliability testing by this research group 11 ; however, it has not been investigated for its ability to monitor change in head and neck lymphedema over time in response to treatment. The lymphedema program at the Princess Alexandra Hospital has been developed through training in recognized methods of lymphedema therapy 12 and international benchmarking with centers of excellence. 13 Reductions in lymphedema have been reported anecdotally; however, to date, these have not been measured systematically over time with the ALOHA system. The aims of this study were: (1) to determine whether there was any change in head and neck lymphedema over a 22-week course of lymphedema treatment; and (2) to determine whether and changes in head and neck lymphedema occurred over the course of 1 single lymphedema treatment session. 2 MATERIALS AND METHODS 2.1 Design This pilot study used a prospective repeated measures observational design and was conducted at a single center, the Princess Alexandra Hospital, Brisbane, Australia. Ethical clearance was received from the hospital ethics board. All participants provided written informed consent for participation. 2.2 Participants Potential participants had been referred for lymphedema treatment and were included in the study if they were: 18 years of age; had previous diagnosis of head and neck cancer treated with curative intent radiotherapy and/or surgery; had a minimum of soft visible reversible external edema of the neck or submental region with no pitting (MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale 1); 3,6 had a life expectancy >12 months; were not pregnant; and had the ability to provide informed consent. 2.3 Measures External head and neck lymphedema was assessed using the ALOHA measurement system, 9,11 including TDC, as assessed by the Delfin MoistureMeter D, taken in the submental region (8-cm inferior to the lip), and tape measurements of the lower neck circumference, upper neck circumference, and ear-to-ear length. As previously reported, these 4 ALOHA tape measurement points and the Moisture- Meter D showed strong interrater reliability and convergent validity. 11 A fifth ALOHA tape measurement point, from the lip to the lower neck circumference, had poor interrater reliability and has consequently been removed from the current assessment protocol. A detailed administration protocol for the ALOHA assessment has been previously published. 9 Participants were further assessed using the established criteria of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale. The MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale is a 4-point scale based on the International Society of Lymphology rating scale 14 with the addition of a level describing soft edema common to the head and neck region. 15 The MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale was used as a measure of the minimally clinically important difference (MCID) in head and neck lymphedema. An MCID is defined as the smallest difference in the score that would mandate a change in a patient s management. 16 A change in one stage level of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale (eg, stage 2 to stage 1b) demonstrates a clinically observable change and, as such, could be considered an objective improvement in head and neck lymphedema and a measure of the MCID. Using a one-level change in the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale as an MCID will enable better clinical interpretation of ALOHA scores. Quality of life data were collected; however, they will be reported as part of a larger study in a future article to allow more in-depth discussion. 2.4 Procedure All assessments were conducted by an assessor who had completed training in head and neck lymphedema management approved by the Australasian Lymphology Association ( and additional training in the use of the ALOHA assessment. Assessments were conducted at the end of treatment sessions in weeks 1, 3 (beginning and end of session), 6, 10, 14, and 22.

3 PIGOTT ET AL FIGURE 1 Treatment schedule [Color figure can be viewed at wileyonlinelibrary.com] Participants received 13 lymphedema therapy treatments over 22 weeks supplemented by daily self-management. The treatment schedule is outlined in Figure 1. Treatments provided included: (1) therapist-administered treatments, which included education about head and neck lymphedema using a consistent presentation detailing the role of the lymphatics; the impact of cancer treatment; and the development and treatment of lymphedema; (2) performance of manual lymphatic drainage for 30 minutes during treatment appointments using the pattern of drainage developed for self-lymphatic drainage; (3) application of Kinesiotape was provided after every treatment appointment in the pattern of drainage developed for self-lymphatic drainage; (4) instruction in self-management and instruction in self-lymphatic drainage; demonstration and written and verbal instructions were provided; the pattern of drainage was customized to the individual; and the participants were requested to perform self-lymphatic drainage daily for 30 minutes; (5) instruction in neck active range of motion exercises, including flexion/extension, rotation, and lateral flexion; and (6) provision of compression (liopmed face compression with a flat foam insert), which the participants were instructed to wear and insert initially during the day for 4 hours then to increase to overnight wear as soon as tolerated. Additionally, they were instructed to use a textured foam insert under the compression for 30 minutes before self-lymphatic drainage/ manual lymphatic drainage. Participants self-management commenced after the first appointment and was reviewed at each subsequent appointment. Participants were requested to perform self-management daily; however, compliance was not monitored. 2.5 Data analysis Data for each timepoint (ie, weeks 1, 3, 6, 10, 14, and 22) were entered into and analyzed using the Statistical Package for the Social Sciences (IBM SPSS Statistics, version 22). Data were screened for missing values, normality, and sphericity. One participant had missing data for 1 timepoint and this was substituted with data from the previous timepoint. Mauchly s test of sphericity was significant for the ear-to-ear measurement, indicating that this variable did not meet the sphericity assumption. Means and SDs for the ALOHA measurements were calculated for each timepoint. To address aim 1, a repeated measures analysis of variance (ANOVA) was used to determine if there was a difference in ALOHA measurements over the 6 timepoints during treatment (weeks 1, 3, 6, 10, 14, and 22). A Greenhouse- Geisser correction was used for the lower neck circumference and ear-to-ear repeated measures ANOVA to ensure reliability due to the presence of a violation of the sphericity assumption in the data distribution. Alpha was set at the 0.05 level for all comparisons. In cases in which the F values were significant, post hoc tests using the Bonferroni correction were conducted to determine between which timepoints there were significant differences. The 95% confidence intervals (CIs) for pairwise comparisons were examined. These were exploratory analyses to determine how many sessions were needed to produce a significant reduction in lymphedema using the ALOHA outcome measurement. To address aim 2, a repeated measures t test was used to compare measurements at the beginning and completion of the treatment session conducted in week 3 of lymphedema treatment. 3 RESULTS Ten participants were recruited for this study. They were most commonly men, aged 65 years, and with a diagnosis of squamous cell carcinoma treated with unilateral surgical lymph node removal and radiotherapy (see Tables 1 and 2 for demographics). Descriptive statistics for the ALOHA measurements over the 6 timepoints showed a steady reduction for all measures (see Figure 2). Repeated measures ANOVAs showed statistically significant differences in the mean measures over time for the lower neck circumference (F (2.15,19.35) ; P 5.004), upper neck circumference (F (5,45) ; P <.001), ear-to-ear measurement (F (2.55,22.95) , p ), and mean TDC (F (5,45) ; P <.001). Post hoc tests revealed significant reductions for the lower neck circumference between week 1 and week 14 (95% CI ), week 1 and week 22 (95% CI 0.63-

4 1134 PIGOTT ET AL. TABLE 1 Demographic variables Demographics Age, years Mean 65.1 Range Sex Male 9 (90%) Female 1 (10%) Cancer type Squamous cell carcinoma 8 (80%) Adenoid cystic carcinoma 1 (10%) Thyroid 1 (10%) Cancer location Oral cavity 1 (10%) Pharyngeal 4 (40%) Laryngeal 3 (30%) Salivary 1 (10%) Other (thyroid) 1 (10%) Lymph node removal Yes 7 (70%) Bilateral 5 (50%) Unilateral 3 (30%) No 2 (20%) Chemotherapy Yes 2 (20%) No 8 (80%) Radiotherapy External beam 9 (90%) Mean dose Gy Dose range 62.2 Gy Unilateral 2 (20%) Bilateral 7 (80%) Radioactive iodine (I-131) 1 (10%) Dose MBq Time from completion Mean 5.9 mo Range 2-14 mo Edema duration Mean Range MD Anderson Cancer Center rating 3 2 (Firm pitting edema, not reversible with no tissue changes 1b (Soft pitting edema, reversible) 6.7 mo 3-12 mo 7 (70%) 3 (30%) 4.15), and week 2 and week 22 (95% CI ); for the upper neck circumference between week 1 and week 14 (95% CI ), week 1 and week 22 (95% CI ), and week 2 and week 22 (95% CI ); and for TDC between week 1 and week 3 (95% CI ), week 1 and week 10 (95% CI ) and week 1 and week 22 (95% CI ). Post hoc comparisons indicated that the differences in ear-to-ear measurements between timepoints did not reach statistical significance after Bonferroni adjustment for multiple comparisons. There were no significant differences in measurements taken before and after a single session of treatment in week 3 (Table 3). Raw data from the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale shows a reduction in the rating of participant lymphedema for 8 of 10 participants (80%; Table 4). Two participants (20%) remained consistent with their MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale score. No worsening of lymphedema was recorded. 4 DISCUSSION There is little robust research available to guide the best practice for head and neck lymphedema treatment or expectations of its success or failure. Previous studies have all described unique treatment programs. Piso et al 16 described a program of manual lymphatic drainage and whole head compression for up to 12 weeks. Huit 17 described an individualized approach of skin care, exercise, simple lymphatic drainage, taping, compression garments and bandages, and the use of textured pads and neck supports with individualized treatment duration. Smith et al 6 described the use of manual lymphatic drainage, compression, exercises, and skin care in a therapist-directed approach for 4 weeks or a patient-directed approach for up to 3 months. Although all of these approaches demonstrated some success and are useful to inform therapists in the field, conclusions about their effectiveness are limited by their study design and lack of formal evaluation using assessment tools with adequate psychometric data. 6,16,17 The current study utilized the standard care program provided for head and neck lymphedema at the Princess Alexandra Hospital. Results across the 22-week treatment course indicated that lower and upper neck circumference and TDC measurements underwent significant reduction indicating the program may have been successful in reducing lymphedema in these areas. Ear-to-ear length did reduce over time with treatment but was not sensitive to change in the final analysis. Significant differences were detected in the neck circumference and TDC measurements between early and later

5 PIGOTT ET AL TABLE 2 Time from cancer treatment completion Participant Surgical lymph node dissection No. of radiotherapy treatments Time from cancer treatment, months 1 Bilateral 30 (60 Gy) 6 2 Bilateral 30 (60 Gy) 3 3 Bilateral 30 (60 Gy) 3 4 Unilateral 30 (60 Gy) 2 5 N/A Radioactive iodine MBq 4 6 Bilateral 35 (70 Gy) 9 7 Bilateral 35 (70 Gy) 11 8 Bilateral 30 (60 Gy) 14 9 Unilateral 30 (60 Gy) 4 10 Bilateral 30 (60 Gy) 3 Abbreviation: N/A, not applicable. treatment sessions but these differences were not found between adjacent timepoints. It is possible that the ALOHA assessment may be more reliable in detecting larger change over the course of an entire treatment program rather than small improvements seen over the space of a few weeks. Alternatively, there may have been a delayed or accumulative response to the treatment provided rather than an immediate effect. The MCID reference for this study was the use of the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale. A change in one level of the scale describes an observable clinical change. This could be considered a generous measure of the MCID for head and neck lymphedema. The MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale scores reduced at least one level for 80% of participants. This provides support for the reduction in ALOHA measurements being a clinically relevant change. No participants showed deterioration in their condition; however, 2 participants did not improve on the MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale. Interestingly, these 2 participants had some of the longer times between finishing cancer treatment and commencing lymphedema treatment. This could reflect other lymphedema studies showing better success with early intervention; however, the finding is not clear in this small sample. 18,19 Future studies could stratify groups based on time since cancer treatment to further examine this influence. The study examined short-term changes in head and neck lymphedema with the repeated measures taken at the start and end of session 3. Significant reductions in outcomes were not found over this 1 treatment session, suggesting it may have been the cumulative effect of multiple sessions FIGURE 2 Mean Assessment of Lymphedema of the Head and Neck (ALOHA) measurements during treatment. TDC, tissue dielectric constant

6 1136 PIGOTT ET AL. TABLE 3 Mean (SD) Assessment of Lymphedema of the Head and Neck measurements during lymphedema treatment Measurement, cms Week 1 (start of session) (end of session) Week 6 Week 10 Week 14 Week 22 Lower neck circumference Upper neck circumference (5.19) (5.30) (4.95) (4.93) (5.06) (5.44) (4.72) (6.17) (6.17) (6.16) (5.97) (5.54) (6.20) (5.46) Ear-to-ear (3.71) (3.32) (3.00) (2.98) (3.13) (3.20) (3.07) MoistureMeter D, TDC (3.46) (6.80) (7.39) (6.50) (5.20) (8.25) (7.51) Abbreviation: TDC, tissue dielectric constant. that led to improvements. However, the small sample size in this study may also have been insufficiently powered to detect small changes using post hoc tests. Response to treatment over short time periods should, therefore, be investigated with a larger sample of participants. The influence of the home program was not tightly controlled or monitored in this pilot study. This element of the program was a large contributor to the overall therapy provided, particularly with respect to the use of compression. Future studies should monitor compliance to allow analysis of the overall influence of the home program. The results indicated that approximately 14 weeks after starting lymphedema treatment, a significant change had occurred in head and neck lymphedema. Further testing is required to determine whether it is the number of sessions (11 prior treatment sessions) or the duration from initial treatment (14 weeks), which is more important for achieving change. Previous studies have provided lymphedema treatment over individualized duration, 17 or up to 12-week 6,16 time periods. Due to the lack of reliable outcome measurements and retrospective study designs used in previous studies, it is difficult to compare those studies with the current study. An important limitation of this study is the lack of a control group. Without a control group it cannot be determined whether change recorded on the ALOHA and MD Anderson Cancer Center Head and Neck Lymphedema Rating Scale was due to the treatment provided or due to natural healing over the study period. Future studies could look to include TABLE 4 MD Anderson Cancer Center stage during lymphedema treatment Participant Week 1 (start of session) (end of session) Week 6 Week 10 Week 14 Week 22 No. of levels change b 2 1b 1b b 1b 1b 2 1b 1a b 1b 1b 1a 1b 1b b 1b 1a 1a 1a no data 1a b 1b 1b 1a 1b 1b b 1b 1b 1b 1b 1b 1b 0 7 1b 1b 1b 1a 1b 1b 1a b 1b 1b 1b 1b b 1b 1b 1b 1b 1b -1 MD Anderson Cancer Centre Head and Neck Lymphedema Rating Scale 3,6 : 0 5 lymphedema without visible edema but with a complaint of tissue heaviness. 1a 5 reversible soft visible edema without pitting. 1b 5 reversible soft pitting edema. 2 5 irreversible firm pitting edema (no tissue changes). 3 5 irreversible tissue changes (eg, hyperkeratosis or papillomatosis).

7 PIGOTT ET AL the use of a control group to address this critical question. In our center, not offering lymphedema treatment would be inconsistent with standard care. However, future studies could consider evaluating 2 different treatment protocols (eg, manual lymphatic drainage vs compression) with monitoring of home program compliance to compare healing rates. 5 CONCLUSION This pilot study has demonstrated that participants undergoing the Princess Alexandra Hospital Head and Neck Lymphedema Treatment Program had a reduction in lymphedema over its 22-week course. This study was a longitudinal pilot study and did not have a control group. As such, the results cannot determine which components of the program contributed to the positive outcomes or whether the treatment provided was effective compared with no treatment. ACKNOWLEDGMENTS The authors thank the study participants who donated their time for this project. CONFLICT OF INTEREST The authors declare that they have no conflicts of interest with the contents of this article. The authors are all employed by the institution in which the research was conducted. The authors have control of the primary data and are able to provide this if requested. ORCID Amanda Pigott BOccThy, PhD REFERENCES [1] Deng J, Ridner SH, Dietrich MS, et al. Prevalence of secondary lymphedema in patients with head and neck cancer. J Pain Symptom Manage. 2012;43(2): [2] Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. A prospective study of the lymphedema and fibrosis continuum in patients with head and neck cancer. Lymphat Res Biol. 2016;14(4): [3] Smith BG, Lewin JS. Lymphedema management in head and neck cancer. Curr Opin Otolaryngol Head Neck Surg. 2010;18 (3): [4] Deng J, Murphy BA, Dietrich MS, Sinard RJ, Mannion K, Ridner SH. Differences of symptoms in head and neck cancer patients with and without lymphedema. Support Care Cancer. 2016;24(3): [5] McGarrvey A, Osmotherly P, Hoffman GR, Chiarelli PE. Lymphoedema following treatment for head and neck cancer: impact on patients, and beliefs of health professionals. Eur J Cancer Care (Engl). 2014;23(3): [6] Smith BG, Hutcheson KA, Little LG, et al. Lymphedema outcomes in patients with head and neck cancer. Otolaryngol Head Neck Surg. 2015;152(2): [7] Flores AM, Spinelli BA, Eden MM, Galantino ML. EDGE Task Force on head and neck cancer outcomes: a systematic review of outcome measures for quantifying external lymphedema. Rehabil Oncol. 2015;33(2): [8] Deng J, Ridner SH, Aulino JM, Murphy BA. Assessment and measurement of head and neck lymphedema: state-of-the-science and future directions. Oral Oncol. 2015;51(5): [9] Nixon J, Purcell A, Fleming J, McCann A, Porceddu S. Pilot study of an assessment tool for measuring head and neck lymphoedema. Br J Community Nurs. 2014;Suppl S6:S8-S11. [10] Deng J, Ridner SH, Murphy BA, Dietrich MS. Preliminary development of a lymphedema symptom assessment scale for patients with head and neck cancer. Support Care Cancer. 2012; 20(8): [11] Purcell A, Nixon J, Fleming J, McCann A, Porceddu S. Measuring head and neck lymphedema: the ALOHA trial. Head Neck. 2016;38(1): [12] F oldi M, F oldi E, eds. F oldi s Textbook of Lymphology: for Physicians and Lymphedema Therapists. 2 ed. Munich, Germany, Elsevier, [13] Purcell A. Head and neck lymphoedema management practices. J Lymphoedema. 2013;8(2):8-15. [14] International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2013 Consensus Document of the International Society of Lymphology. Lymphology. 2013;46(1):1-11. [15] Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4): [16] 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;80 (4): [17] Huit M. Lymphoedema in patients treated for head and neck cancer. J Lymphoedema. 2011;6(1): [18] Torres Lacomba M, Yuste Sanchez MJ, Zapico Go~ni A, et al. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010;340:b5396. [19] Shah C, Arthur D, Wazer D, Khan A, Ridner S, Vicini F. The impact of early detection and intervention of breast cancerrelated lymphedema: a systematic review. Cancer Med. 2016;5 (6): How to cite this article: Pigott A, Nixon J, Fleming J, Porceddu S. Head and neck lymphedema management: Evaluation of a therapy program. Head & Neck. 2018;40: