History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
Edema or lymphedema in the lower limbs > grade 2
A diagnosis of head and neck lymphedema.
Completion of phase 1 lymphedema care in the past 8 weeks;
Inclusion Criteria:\n\n 1. Has a diagnosis of secondary leg lymphedema, based on a positive lymphoscintigraphy\n (LSG) study of the affected leg OR has a diagnosis of primary lymphedema not of\n congenital onset affecting one or both lower limbs, based on positive LSG.\n\n 2. Swelling of at least 1 leg not completely reversed by leg elevation or compression.\n\n 3. Stage II or greater lymphedema, based on the International Society of Lymphology (ISL)\n staging system.\n\n 4. Completion of a full course of complete decongestive therapy (CDT).\n\n 5. Stable limb volume (within 10% during screening for worse/affected leg) .\n\n 6. If patient has had a lymphatic vascularization procedure (lymphovenous bypass or lymph\n node transfer) or liposuction for lymphedema in the affected limb, then procedure must\n have been performed at least 1 year (12 months) prior to Screening AND affected limb\n must be clinically stable over the 3 months prior to Screening AND significant\n residual disease must be present.\n\n 7. Ambulatory status (use of a walking aid is permitted).\n\n 8. Agree to use a medically acceptable method of contraception, if the possibility of\n conception exists.\n\n Exclusion Criteria:\n\n Exclusions Based on Lymphedema:\n\n 1. A diagnosis of primary lymphedema with congenital onset. Primary lymphedema is defined\n as lymphedema with onset prior to or without an inciting event (e.g, surgery, trauma,\n radiation)\n\n 2. Occurrence of significant lymphedema of another body part that is not the lower limb\n (e.g, upper extremity, trunk, head and neck, genitalia).\n\n 3. Lymphedema involving all four limbs\n\n 4. Recent initiation of, or intention to initiate CDT or maintenance physiotherapy for\n lymphedema.\n\n Exclusions Based on Other Medical Conditions\n\n 5. Deep venous thrombosis in either lower limb or systemic anticoagulation within 6\n months\n\n 6. Other medical condition that could lead to acute or chronic leg edema.\n\n 7. Other medical condition that could result in symptoms overlapping those of lymphedema\n in the affected leg.\n\n 8. History of clotting disorder (hypercoagulable state).\n\n 9. Chronic (persistent) infection in either lower limb.\n\n 10. Cellulitis or other infection in either lower limb or use of antibiotics for\n cellulitis within 3 months prior to screening.\n\n 11. Other unstable or severe medical condition requiring active management and/or likely\n to decompensate/require active management within the next year\n\n 12. Current evidence of malignancy.\n\n 13. History of malignancy within the previous 3 years, except for nonmelanoma skin cancer\n or cervical carcinoma in situ treated with curative intent.\n\n 14. Currently receiving chemotherapy or radiation therapy.\n\n 15. Life expectancy < 2 years for any reason.\n\n 16. Pregnancy or nursing.\n\n 17. Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening.\n\n Exclusions Based on Concurrent Medication Use\n\n 18. Regular concurrent use or regular use within 6 months before screening of another\n leukotriene pathway inhibitor.\n\n 19. Concurrent antibiotic use.\n\n 20. Concurrent use of any agent active on the sphingosine-1-phosphate (S1P) pathway.\n\n 21. Concurrent use of unapproved (including herbal) treatments for lymphedema.\n\n Exclusions Based on Laboratory Values\n\n 22. Significant or chronic renal insufficiency or requires dialytic support.\n\n 23. Hepatic dysfunction.\n\n 24. Absolute neutrophil count <1500 mm3 at screening.\n\n 25. Hemoglobin concentration <9 g/dL at screening.
Patients with dermal change indicative of lymphedema or phlebolymphedema. disease.
Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
Stage III lymphedema
Have been diagnosed with lymphedema (LE) at least one year prior to study enrollment
Have arm lymphedema on one side only
Lymphedema Group: Lymphedema, symptomatic of stage II or III based upon screening responses; or lymphedema index (L-Dex) reading of >= 7 at initial visit
Lymphedema Group: > 3 months (mths) post-breast cancer treatment
Lymphedema Group: No active cancer
Lymphedema Group: Has compression sleeve
Lymphedema Group: Willing to do guided and home yoga practice
Lymphedema Group: Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
Lymphedema Group: Medical clearance
Lymphedema Group: Reliable transportation to the study site
No Lymphedema Group: No known lymphedema or intermittent swelling, not symptomatic of stage II or III lymphedema (L-Dex >= 7)
No Lymphedema Group: > 3 mths post- breast cancer treatment
No Lymphedema Group: No active cancer
No Lymphedema Group: Willing to do guided and home yoga practice
No Lymphedema Group: Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
No Lymphedema Group: Medical clearance
No Lymphedema Group: Reliable transportation to the study site
Current lymphedema treatment
No more than 6 weeks after completion of initial lymphedema therapy for head and neck lymphedema
Stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)
Presence of other extremity lymphedema (primary or secondary)
No active lymphedema
Unmanaged lymphedema
Patients may or may not have a history of lymphedema or have been treated for lymphedema
Patients who have lymphedema due to cancer recurrence
Lymphedema of the upper extremities, as detected on history and physical
Previous diagnosis of lymphedema
Stage II lymphedema based upon International Society of Lymphedema (the limb is firm in places, elevation does not reduce swelling, it may or may not pit with pressure, and skin changes may be noted)
Prior diagnosis of lymphedema
Unilateral upper limb secondary lymphedema
Intermediate phase lymphedema; defined clinically as significant persistent pitting edema on physical exam
Patient undergoing concomitant treatment for upper extremity lymphedema, or who have received treatment within the last 14 days
Patients on diuretics solely for treatment of lymphedema are excluded
Patient with primary lymphedema; if edema can be explained by systemic or congenital illnesses, that patient will not be eligible for this study
Patients with malignant lymphedema
Grade III lymphedema or lymphedema considered severe by the treating clinician
Knowledgeable in either HNC or lymphedema management or informatics
LYMPHEDEMA THERAPISTS:
Certified lymphedema therapists
Knowledgeable in head and neck lymphedema management
Completion of lymphedema therapy for lymphedema of the head and neck
Able to complete the onsite training and home self-care activities for lymphedema management
Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years; this timeframe allows ample time for any surgically related non-lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years will capture the broadest range of cases, and has been used as a timeframe in several studies including our pilot study
Bilateral lymphedema
Previous acupuncture treatment for lymphedema
History of primary (congenital) lymphedema
Grade III lymphedema or lymphedema considered severe by the treating clinician
Previous treatment for lymphedema of either arm.
HEALTHY VOLUNTEER: Lymphedema or chronic edema
History of primary lymphedema
Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)
