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Risk Reduction in the News – Response from the NLN Medical Advisory Committee
2012 Conference featured in Oncology Times
Clinical Trials - Patient Participation
NLN Position Papers: Risk Reduction, Risk Reduction Summary, Diagnosis and Treatment, Exercise, Training, Breast Cancer-Related Lymphedema, Supplement BC-Related LE
By: Joy C. Cohn, PT, CLT- LANA, Penn Therapy and Fitness, Good Shepherd Penn Partners, Philadelphia, PA
Marilyn L. Kwan, PhD, Division of Research, Kaiser Permanente, Oakland, CA
Introduction
The American Medical Association has teamed with the American College of Sports Medicine (ACSM) for an initiative called “Exercise is Medicine”.1 One of the primary recommendations of this initiative is that 150 min of physical activity each week is important to gain health benefits for all individuals. But for many individuals with lymphedema, this recommendation is difficult to understand and follow due to lack of information about whether exercise is safe for those diagnosed with or at risk for this condition. In addition, some of the common co-morbidities associated with lymphedema, for example, obesity and diabetes, are also conditions for which exercise is an important component of managing the condition. For cancer patients, the majority of whom are at lifetime risk for/or have lymphedema, there is a growing body of literature to encourage exercise throughout their treatment and subsequent survivorship. Due to all of these issues, the question of whether exercise is safe is important.
The International Lymphoedema Framework (ILF) published a Best Practice document in 2006 based upon a review of the literature through 2004. This document and subsequent publications have been written to provide guidance for the management of lymphedema patients and for individuals at risk. The American Lymphedema Framework Project (ALFP), established in the United States in 2008, was subsequently charged to continue the systematic review of the available medical evidence and collaborate with the ILF in updating the best practice documents. Groups of clinicians, researchers, and advocates with expertise in lymphedema were invited to participate in systematically reviewing the literature for publication on many topics related to lymphedema management. The systematic review of surgery in lymphedema was discussed in LymphLink in a previous issue (Vol. 24 No. 2, pp 3).2 A systematic review of the literature from 2004 to 2010 examining the evidence of exercise in individuals with lymphedema was completed and published in 2011.3
Publications with the appropriate search terms were retrieved from 11 major medical index databases.3 Articles were reviewed using inclusion criteria by lymphedema experts, yielding 35 articles for final inclusion as evidence related to exercise. Study evidence was classified using the ‘Putting Evidence into Practice’ (PEP) classification system described by the Oncology Nursing Society.4 Details of study design and objectives, number of participants, study outcomes, intervention used, results, and strengths and weaknesses were tabulated and presented for subsets grouped by the major type of exercise studied. The subsets were: Resistance Exercise, Combined Aerobic and Resistance Exercise, and Other. Please see the article for specific details of the PEP classification and tabulated details of each study.3
Resistance Exercise
There were seven studies representing 599 participants included for resistance (primarily weight lifting) exercise. The evidence from these studies were classified as ‘Likely to be Effective’ by the PEP criteria. The PAL Trial included in this series by Schmitz et al. represents the largest randomized clinical trial published to date with the longest follow-up at one year which evaluated progressive weight lifting in women with a unilateral breast cancer.5, 6 Half (n=141) of the women had a diagnosis of lymphedema and the other half (n=154) were at risk for lymphedema. A control group was identified for each arm of the study, and each group was asked to not change their exercise habits during the course of the study. The intervention groups were instructed in an exercise program including a warm-up, flexibility, core exercises and progressive weight lifting exercises for the upper and lower body. The women with a lymphedema diagnosis were fitted with a custom compression arm sleeve and glove to wear during the exercise sessions. The exercises were taught in a group setting in community fitness centers led by a trainer who had been educated about the intervention and how to monitor for lymphedema symptoms. This setting was chosen in anticipation of possible dissemination of the exercise regimen, if found effective and safe. The participants exercised twice per week for six months with supervision by the trainers.
The main outcome was a change in volume of the hand and arm at one year, with an absolute increase in volume of 5% in comparison of the affected and unaffected limbs. Other outcomes reported were lymphedema symptoms, muscle strength, and exacerbations of lymphedema. Any participant who reported a change in arm symptoms that lasted for more than one week (the definition of a potential exacerbation) was evaluated by a lymphedema therapist with treatment provided, if indicated. In this group of women with lymphedema who exercised, weight lifting did not increase the severity of their limb lymphedema. Instead, the exercise decreased the number and severity of reported symptoms; increased their strength; and reduced the number of exacerbations of lymphedema, as compared with the non-exercising control group.5
The PAL Trial also investigated the effects of the same exercise intervention in women at risk for lymphedema, and the results were even more striking.6 The exercise group did not have an increased risk in the onset of lymphedema: 11% (8/72) in the weight-lifting group as compared to 17% (13/75) in the control group experienced BCRL onset during the study period. (p=0.04). In a separate analysis, in the subgroup of women who had ≥5 lymph nodes removed, only 7% of the exercise group (3/45) versus 22% (11/49) of the control group experienced BCRL onset (p=0.003). The two reported arms of PAL Trial both demonstrate that weight lifting is a safe intervention in breast cancer survivors with or at risk for lymphedema.
The Weight Training for Breast Cancer Survivors trial looked at the effect of a weight training program in 45 breast cancer survivors at risk for lymphedema due to an axillary node dissection as part of their cancer treatment.7 Half of the women (23/45) met twice weekly over six months for resistance exercise. The other half (22/45) were asked to not change their exercise level during the study. Women in the study were not required to wear compression garments, but did so if previously given medical advice to do so. The results again demonstrated that there was no difference in arm circumferential measurements or reported symptoms of lymphedema.
Another large randomized clinical trial including 204 women with breast cancer and had axillary node dissection compared two programs of rehabilitation.8 One group was instructed to restrict their activities of daily living (ADLs) while the other group made no changes in their ADLs and lifted weights for increased strength. The “no restrictions group” participated in a clinic-based program of moderate resistance exercise 2-3 times/week for six months. The “restrictions group” was asked to restrict their ADLs by avoiding heavy or strenuous activities and participating in a ‘usual care’ physical therapy program once per week for the same six-month time frame which was not described further. Arm volumes increased over time in both groups in both at risk and unaffected limbs. There was no significant difference, however, in comparing arm volumes between the restrictions and no restrictions groups.
Several small studies investigated resistance exercise interventions using free weights or Theraband resistance bands.9-11 These studies also demonstrated no adverse effects related to lymphedema symptoms and significant improvements associated with resistance exercise in symptoms and strength. In one study with 19 participants who had lymphedema , the participants all followed an unsupervised exercise program of range of motion (ROM) and light resistance exercises, but one half of the participants wore a compression garment.11 In the group wearing a compression garment, significant decreases in measurements in the distal part of the arm at several timepoints were observed. In the non-compression group, a significant decrease was seen in the upper arm, but only at the initial measurement.
Combined Aerobic and Resistance Exercise
There were seven studies representing 318 participants that examined the effects of aerobic and resistance exercise.12-18 The studies reviewed were small in size with the exception of one RCT with 242 participants, or were literature reviews. The preponderance of evidence was classified as ‘Benefits balanced with harm.’
The Supervised Trial of Aerobic versus Resistance Training represented the largest study.19 It was conducted with 242 breast cancer patients in Canada during their adjuvant chemotherapy treatment. This was a multicenter RCT with participants assigned to one of three possible interventions: Usual Care (82/242), supervised weightlifting (82/242), or supervised aerobic exercise (78/242). The intervention continued throughout planned chemotherapy treatment. The primary outcomes of this study were quality of life, fatigue, depression, and anxiety. Lymphedema was reported as a secondary outcome and did not occur in any group studied during or post-intervention when assessed up to six months after chemotherapy.
The systematic reviews uniformly stated that there was no evidence to suggest that exercise was the cause of lymphedema in those at risk or caused an exacerbation in those studies including participants with primarily BCRL. One review included 38% of participants who had prostate cancer or other cancer20. A literature review of 218 articles to assess effective interventions in the treatment of lymphedema concurred in classifying combined exercise interventions as ‘Benefits balanced with harm’ using the PEP criteria.21
Other Exercise Interventions
This group of five studies that primarily studied standard post-operative physical therapy interventions included, but were not limited to, exercise in generally the immediate post-operative period.22-26 These studies were uniformly small, represented varied treatment programs that included but were not limited to exercise, had short follow up periods, and were not designed to assess lymphedema as the primary outcome. ROM of the shoulder girdle, pain, and function were the major study outcomes. One 2010 study examined lymphedema as the primary outcome, but the intervention included manual lymphatic drainage, scar mobilization, and exercise.26 The control group did have a higher reported incidence of lymphedema at one year follow-up.
Compression Garments During Exercise
It was noted that, other than the PAL Trial in women with diagnosed BRCL, none of the reviewed studies commented specifically on the necessity for compression garments during exercise. Some studies notes that if recommended, some participants wore compression during the studied interventions. Other studies did not mention compression usage. During treatment of lymphedema by complete decongestive therapy as described by the NLN in their Position Paper on treatment, remedial exercises are prescribed with compression on the limb to enhance the musculoskeletal pump leading to greater decongestion of the limb.27 The NLN Position Paper on exercise currently states that “most experts in the field of lymphedema advise the use of compression during vigorous exercise for people with a confirmed diagnosis of lymphedema”. The NLN Medical Advisory Committee (MAC) noted, as we did in this review, that the evidence is not available to definitively recommend compression during exercise. The MAC recommends compression class 1 garments (20-30 mmHg) at minimum for the upper extremity and noted that lower extremity or more severe lymphedema of any type would require higher levels of compression garments. They also recommend that compression garments should be fitted by trained individuals, and specifically in the upper extremity, should provide compression
to the hand as well as the arm.
Summary of the Systematic Review and Recommendations
The evidence in the more recent medical literature is strong regarding the safety of guided exercise in the breast cancer population without increasing the risk of developing or increasing lymphedema. However, most of the published studies are in the breast cancer population and therefore provide less guidance to individuals who are at risk for or have a diagnosis of lymphedema from other etiologies. A roundtable on exercise convened by the ACSM published exercise guidelines specifically for cancer survivors.28 The strongest recommendation of this panel is to “Avoid inactivity,” and this recommendation is made for all periods of cancer survivorship, beginning at diagnosis.
“Physical Activity” is the broader term used in the medical literature to describe any and all forms of movement that is the opposite of inactivity. Studies on physical activity and its benefits have been described for many illnesses/diseases, as well as for simply sedentary individuals. The study results apply to all of us and argue for incorporating exercise into our daily regimes, no matter what other conditions we might have. The exercise programs reported in this systematic review have several themes in common. They recommend a slow, progressive approach to increase repetitions and weight (or other forms of resistance), regular exercise sessions performed 2-3 times per week, and monitoring of increase in symptoms that might indicate the onset or increase in lymphedema. The PAL Trial, in particular, educated patients to not ignore any change in symptoms that lasted more than seven days.
The health benefits of physical activity are strongly associated with: coronary artery disease, diabetes, hypertension, colon cancer, mental health, bone health, strength, flexibility, endurance for daily activities, and obesity.29 A recent review of ‘exercise therapy’ states that, “It is now undeniable that sedentary lifestyles are one of the most significant public health problems of the 21st century.”30 As a society, we do less physical labor at work and home, we travel more often by car, and our entertainment consists of far more sedentary activities such as TV
and digital entertainment in all of its many forms!
Many individuals consider ‘exercise’ a complicated undertaking that requires equipment, a gym membership, or spandex shorts. At Penn Therapy and Fitness, our often-stated mantra is that ‘Asphalt is free.’ Beginning an exercise program by a simple walk each day, with the goal of increasing the time spent in uninterrupted walking to 30 minutes, five days per week over a month or two, meets the AMA/ACSM guideline of 150 minutes per week of physical activity. This is a goal that all individuals can meet, with medical guidance, if needed. With regards to lymphedema, seeking advice regarding treatment or a compression strategy is indicated if symptoms of achiness, heaviness, or an increase in swelling are experienced with exercise. Exercise, as part of an effective weight loss program, can assist in reducing lymphedema symptoms in individuals who are overweight. Occasionally, other simple forms of physical activity can be substituted for walking if necessary. Many exercise professionals, including therapists and trainers, can assist in developing a program individualized to your needs. Therefore, it is ultimately possible for every one of us, regardless of health status, to be physically active.
References available online www.lymphnet.org
Joy.Cohn@uphs.upenn.edu;
Marilyn.L.Kwan@lcp.org
By: Constance M. Chen, MD, MPH
Plastic and Reconstructive Surgery Department, New York Eye & Ear Infirmary, New York, NY
Disclaimer
"The following article reports preliminary results from ongoing work in Lymph Node Transfer to address lymphedema resistant to CDT treatment. There are still no studies with large numbers of patients reporting good outcomes with long term follow-up. The NLN and the lymphedema community eagerly await that data."
Background
Over the last several years, there has been increasing interest in a surgical treatment for lymphedema. Both upper and lower extremity lymphedema, whether primary or secondary, is disfiguring and painful, and can cause enduring physical, emotional, social and economic problems. One potential surgical solution, autologous lymph node transfer (ALNT), has been performed in France by Dr. Corinne Becker for 20 years, but minimal clinical data has been published on the efficacy of the procedure. To answer questions about the effectiveness of ALNT, we have been collecting both anthropometric data and patient-reported outcome (PRO) measures on ALNT for the treatment of chronic lymphedema.
To investigate the effectiveness of ALNT for chronic post-mastectomy lymphedema patients, we designed a double-blinded randomized controlled clinical trial. Very soon, however, it became evident that patients who had already exhausted conservative treatment were unwilling to be randomized. All patients undergoing surgery requested to be randomized to the treatment arm, even with the knowledge that the efficacy of the procedure remained in question. In addition, patients with different types of lymphedema presented for treatment, including patients with upper extremity lymphedema, lower extremity lymphedema, primary lymphedema, and secondary lymphedema. Given this, the study design evolved to a prospective observational study of patients with upper or lower extremity lymphedema who had exhausted conservative treatment.
We were comfortable proceeding with ALNT for both upper and lower extremity lymphedema, primary and secondary lymphedema, because we operated under the guidance of Dr. Corinne Becker. In order to ensure patient safety, Dr. Becker traveled to our hospital and was directly involved in patient evaluation and care. Over the last 20 years, Dr. Becker has performed approximately 4000 ALNT for all types of lymphedema. Anecdotally, she has reported impressive results, but the paucity of published objective data has resulted in skepticism among many healthcare providers in the lymphedema community. By having Dr. Becker oversee the clinical aspect of the procedure, we felt confident that the technique and method employed was consistent with the best practices for ALNT. Since she developed the system for treatment, her technique could be considered the gold standard for ALNT. Furthermore, if our data did not reveal efficacy after treatment, we felt confident that it would not be due to inadequate execution of the ALNT technique.
With ALNT selected as a surgical intervention for objective evaluation, we attempted to systematically measure the results of treatment. In the lymphedema literature, there is controversy over the ideal method for measuring lymphedema treatment outcomes. Traditionally, water displacement has been used, but it is messy, inconvenient, and imprecise. Lymphoscintigraphy has been used to map lymphatic channels, but the results are inconsistent and the subdermal injection is painful for patients. Infrared perometry may be considered the modern volumetric gold standard, and we were fortunate to work with a nurse researcher who was willing to conduct preoperative limb measurements of patients with lymphedema. The same researcher also obtained preoperative bioimpedence measurements of fluid in limbs with lymphedema. Preoperatively, we routinely obtained preoperative magnetic resonance angiography (MRA) of the affected and unaffected limb to document preoperative lymphatic fluid and nodal status. Finally, we obtained preoperative PRO measures using the SF-36 and the Breast Cancer and Lymphedema Symptom Experience Index (BCLSEI).
Funding limitations, however, precluded routine postoperative follow-up measurements using infrared perometry, bioimpedence, MRA, and PRO measurements. Instead, the only measurements that could be consistently obtained were preoperative and postoperative circumferential tape measurements of the affected and unaffected limb. In the future, with adequate research funding, we hope to supplement the circumferential tape measurements with postoperative infrared perometry, bioimpedence, MRA, and PRO measurements for more complete and sophisticated postoperative data.
Methods
This was a prospective observational study of 28 consecutive ALNTs performed between 2011 and 2012 at New York Eye & Ear Infirmary (NYEEI) for treatment of chronic recalcitrant lymphedema. Patients treated had upper extremity lymphedema, lower extremity lymphedema, primary lymphedema, or secondary lymphedema. All patients had exhausted conservative treatment with complete decongestive therapy (CDT). Dr. Corinne Becker supervised the clinical procedure to ensure standardization of the surgical technique. The successful revascularization of all ALNT flaps was confirmed intraoperatively with use of the SPY imaging device. Patient characteristics analyzed included age, body mass index (BMI), previous episodes of cellulitis, and iatrogenic causes of disease. The affected and unaffected limb was measured preoperatively and postoperatively using circumferential tape measurements. The difference in preoperative and postoperative measurements between the affected limb was compared and graphed. This was calculated by using the following formula:
((postoperative measurement – preoperative measurement) / preoperative measurement) x 100 = % change.Preoperative and postoperative photographs were also taken to document visual outcomes.
All patients were advised that ALNT was not a proven technique, and signed a detailed 8-page research informed consent in addition to the standard hospital surgical informed consent. Risks discussed with the patient included donor site lymphedema, donor and/or recipient site hematoma and/or seroma, postoperative infection, no improvement in lymphedema, and need for further procedures. All patients underwent postoperative manual lymphatic drainage by a certified lymphedema therapist within one month after surgery to encourage movement of lymphatic fluid toward the newly transplanted lymph nodes.
Results
From 2011-2012 at NYEEI, 28 consecutive ALNTs were performed for treatment of chronic recalcitrant lymphedema. Of the 28 ALNTs, there were 13 ALNTs performed for upper extremity lymphedema (46.4%), 15 ALNTs for lower extremity lymphedema (53.5%), 3 ALNTs for primary lymphedema (10.7%), 20 ALNTs for secondary lymphedema (71.4%), and 5 ALNT for lymphedema of unknown etiology (17.9%). The mean age was 51.8 years (range 28-65 years). The mean BMI was 28.4 (range 18.2-51.4). Of the 28 ALNTs, 6 patients had experienced previous bouts of cellulitis due to their lymphedema (21.4%). Of the 20 ALNTs performed for secondary lymphedema, 13 ALNTs were performed for upper extremity lymphedema due to treatment for breast cancer (65%), 4 ALNTs were performed for lower extremity lymphedema due to treatment for cervical cancer (29%), 2 ALNTs were performed for lower extremity lymphedema secondary to trauma (10%), and 1 ALNT was performed for lower extremity lymphedema due to treatment for melanoma (5%). With regard to postoperative complications, 1 patient experienced a postoperative seroma (3.6%), 1 patient had postoperative cellulitis (3.6%), and 1 patient underwent an additional ALNT to the same affected limb to further reduce extreme girth due to lower extremity elephantiasis (3.6%). See Table 1 for individual patient summaries.
For all patients, the affected limb was measured preoperatively and postoperatively using circumferential tape measurements. Preoperative and postoperative photographs were also taken to document visual outcomes. Examples of preoperative and postoperative graphs and photo documentation for one upper extremity lymphedema patient and one lower extremity lymphedema patient are presented below.
Patient #1 (Upper Extremity Lymphedema)
Patient #1 was a 43-year-old woman with a 2-year history of right upper extremity lymphedema that was not improving with conservative treatment (Figure 1). The patient underwent right partial mastectomy and radiation (Chemotherapy?) in November 2008 followed by radiation therapy in March 2009. In February 2010, the patient cut her finger and developed right upper extremity swelling. She began seeing a lymphedema therapist, and underwent complete decongestive therapy (CDT) every 6 months with lymphatic massage, bandaging, and compression garments. She was 5'8" and 202 pounds (BMI 30.7), and her preoperative MRA demonstrated edema in her forearm to her mid-humerous with dilated lymphatics consistent with lymphedema. Her subcutaneous tissues in her right forearm were 2.8 cm in thickness compared to a maximum thickness of 1.5 cm in her left forearm (Figure 2).
On 3 July 2012, the patient underwent ALNT from her left groin to her right axilla. She had an uneventful postoperative recovery, and went home on POD#1. Within the first week, she noticed a decrease in swelling in her right hand. Within one month, the decreased swelling was noticeable throughout her right arm, and her entire arm felt softer and less fibrotic (Figure 3). By two months, preoperative and postoperative tape measurements revealed a 5.6% reduction in the difference between her preoperative and postoperative affected arm circumferences (Figure 4). Throughout this time, the patient underwent manual lymphatic massage with a certified lymphedema therapist. Overall, she reported a significant decrease in swelling, and stopped wearing her upper extremity compression garment except for rigorous activities.
Patient #2 (Lower extremity lymphedema)
Patient #2 was a 56-year-old woman with a 19-year history of right lower extremity lymphedema after minor trauma. The patient reported that she fell from a chair and sustained a contusion and possible laceration but no fractures. After her fall, her right lower leg swelled up and the swelling never subsided. She went to a physical therapist for her right lower extremity swelling, and was treated with ice and exercises. She also went to two separate vascular surgeons, who did extensive testing before diagnosing her with right lower extremity lymphedema. Once diagnosed, the patient began treatment with compression stockings, which she wore continuously for 19 years. She also completed three courses of CDT, and used a compression pump at home for 3 years. Although she did not have problems with cellulitis, the patient found it difficult to find shoes that fit her, and her toes cracked and bled. In 2001, the patient states that her right lower extremity lymphedema worsened significantly, but then improved when her current lymphedema therapist began wrapping her aggressively from hip to toes in 2008. Her primary complaint was the sheer size of the swelling, which caused pain and discomfort (Figure 5).
Prior to surgery, the patient felt defeated and spent several hours a day wrapping her leg and using her compression pump. Her symptoms included significant right lower extremity swelling and heaviness. She was 5'5" and 155 pounds (BMI 25.8), and her preoperative MRA demonstrated subcutaneous edema in her right calf and lower thigh, with no popliteal lymph nodes (Figure 6).
On 15 March 2012, the patient underwent ALNT from her left lateral thoracic region to her right knee. She had an uneventful postoperative recovery, and went home on POD#1. Within the first week, she stated that her right lower leg was tingling and felt like it was "waking up." By six weeks, the patient stated that her right lower leg felt softer, less tight, and the girth had decreased (Figure 7). She was able to wear shoes that she was not able to fit into before surgery., Throughout this time, the patient continued wearing a lower extremity compression garment, and underwent manual lymphatic massage with a lymphedema therapist. At five months, her preoperative and postoperative tape measurements revealed an 8.3% reduction in the difference between her preoperative and postoperative affected leg circumferences (Figure 8).
Discussion
In order to better understand the outcomes of ALNT, we attempted to quantify objective results with preoperative and postoperative anthropometric measurements of upper and lower extremity lymphedema after ALNT. In the short time period described, there was striking subjective improvement in symptoms described by the patient, which was contrasted with modest objective improvement in measurements collected by the researcher. Visual outcomes were sometimes less dramatic than the personal progress reported by the patient. The individual nature of lymphedema symptoms and effects could make it difficult for a third party to fully understand improvements described by the patient.
In addition, the task of gathering outcome measures before and after ALNT for chronic recalcitrant lymphedema proved to be gargantuan and humbling, as there was often resistance from patients, practitioners, and even fellow researchers with regard to data collection. Once patients experienced improvement, it was often difficult to convince them to return for follow-up. For patients who were from out of town, the economic realities of long-distance travel made frequent visits unrealistic. In addition, many patients experienced emotional ups and downs with regard to their progress. Significant leaps forward could be followed by plateaus in progress, and many patients required a significant amount of support during their recovery.
In sum, the improvements after ALNT for treatment for chronic recalcitrant lymphedema were often experienced by the patient in small private ways. For example, one patient described not being afraid of the summer season anymore, because she knew that she would not have to worry that her arm would "explode" with the heat. While the goal of ALNT for treatment of lymphedema may be complete resolution of lymphedema that obviates further need for compression garments and lymphedema therapy, this did not seem to be a goal that was reached quickly after surgery. Despite this, all patients seemed to universally report improvement with lymphedema in ways that affected their lives that were personally important. This was true even when their subjective experience of the disease was correlated with only modest improvements in objective measurements. In the long term, we will continue to observe how far ALNT can go in helping patients with upper and lower extremity lymphedema in the hope that they can live their lives free from the burdens of disease.
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