LYMPHA: Eliminating the Burden of Lymphedema in Patients Requiring Nodal Dissection

NCT03073096 | Terminated

• 1 other identifier: 20170146 form 6131
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphedema is the build-up of lymph fluid in the body's tissue causing chronic, debilitating swelling. This commonly occurs as a result of a disruption of the lymphatic system during lymph node dissection surgeries. In melanoma patients, the incidence of lymphedema ranges from 5-10% in the arms following an axillary dissection, and 28-40% in the legs following groin dissection. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an innovative microsurgical technique where blocked lymphatic vessels are drained into the blood circulation by surgically creating a shunt between a lymphatic channel and a blood vessel called a lymphatic-venous bypass. Recently, LYMPHA has been shown to prevent lymphedema when performed at the time of nodal dissection. We propose a prospective pilot study evaluating the practice of the LYMPHA technique for the primary prevention lymphedema at The Ottawa Hospital. The novel use of the LYMPHA technique holds the potential to prevent lymphedema rather than to attempt to treat it once it has already progressed and as a result will not only improve the quality of life of the cancer patients, but also decrease health care costs associated with treating lymphedema.

Conditions

Lymph Node Disease

Keywords

axillary nodal dissection; groin nodal dissection

Outcome Measures

Primary Outcomes (1)

• Difference in limb volume between surgery-affected and surgery-unaffected limb at baseline, 3, 6, 9, 12 and 24 months

  At each follow-up visit, patients will have a physical examination and their circumferential limb measurements will be taken with measuring tape at three specific intervals up the limb. For example, patients undergoing an axillary dissection will have the circumference of their wrist taken, and then again 4 cm proximal to the wrist, then 8 cm proximal to the wrist, and so forth. The method will be used for the legs but starting at the ankle. Volume will be calculated indirectly, using Dr. Brorson's truncated cone method.

  every 3 months up to a year, again at year 2

Secondary Outcomes (1)

• Limb-lymphedema-specific Quality of life assessment at baseline, 3, 6, 9, 12 and 24 months through the LYMQOL questionnaire

  every 3 months up to a year, again at year 2

Study Arms (1)

Intervention arm

OTHER

LVA at time of nodal dissection

Procedure: LVA at time of nodal dissection

Interventions

LVA at time of nodal dissection PROCEDURE

Patients will receive a lymphatic-venous anastomosis at time of their required nodal dissection

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed primary melanoma, soft tissue sarcoma, squamous cell carcinoma or merkel cell carcinoma of the trunk or chest.
• Node-positive cancer requiring an axillary or groin lymphadenectomy

You may not qualify if:

• Patients receiving a sentinel lymph node biopsy alone
• Patients with a cancer on the upper or lower extremities are excluded (i.e. arms or legs).
• Patients with established preoperative lymphedema
• Patients with post-thrombotic syndrome, peripheral vascular disease
• Pregnant patients

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Related Publications (11)

• Feldman S, Bansil H, Ascherman J, Grant R, Borden B, Henderson P, Ojo A, Taback B, Chen M, Ananthakrishnan P, Vaz A, Balci F, Divgi CR, Leung D, Rohde C. Single Institution Experience with Lymphatic Microsurgical Preventive Healing Approach (LYMPHA) for the Primary Prevention of Lymphedema. Ann Surg Oncol. 2015 Oct;22(10):3296-301. doi: 10.1245/s10434-015-4721-y. Epub 2015 Jul 23.

  PMID: 26202566 BACKGROUND

• Boccardo F, Valenzano M, Costantini S, Casabona F, Morotti M, Sala P, De Cian F, Molinari L, Spinaci S, Dessalvi S, Campisi CC, Villa G, Campisi C. LYMPHA Technique to Prevent Secondary Lower Limb Lymphedema. Ann Surg Oncol. 2016 Oct;23(11):3558-3563. doi: 10.1245/s10434-016-5282-4. Epub 2016 May 24.

  PMID: 27221358 BACKGROUND

• Morotti M, Menada MV, Boccardo F, Ferrero S, Casabona F, Villa G, Campisi C, Papadia A. Lymphedema microsurgical preventive healing approach for primary prevention of lower limb lymphedema after inguinofemoral lymphadenectomy for vulvar cancer. Int J Gynecol Cancer. 2013 May;23(4):769-74. doi: 10.1097/IGC.0b013e318287a8e8.

  PMID: 23485932 BACKGROUND

• Boccardo F, Casabona F, De Cian F, Friedman D, Murelli F, Puglisi M, Campisi CC, Molinari L, Spinaci S, Dessalvi S, Campisi C. Lymphatic microsurgical preventing healing approach (LYMPHA) for primary surgical prevention of breast cancer-related lymphedema: over 4 years follow-up. Microsurgery. 2014 Sep;34(6):421-4. doi: 10.1002/micr.22254. Epub 2014 Mar 26.

  PMID: 24677148 BACKGROUND

• Torrisi JS, Joseph WJ, Ghanta S, Cuzzone DA, Albano NJ, Savetsky IL, Gardenier JC, Skoracki R, Chang D, Mehrara BJ. Lymphaticovenous bypass decreases pathologic skin changes in upper extremity breast cancer-related lymphedema. Lymphat Res Biol. 2015 Mar;13(1):46-53. doi: 10.1089/lrb.2014.0022. Epub 2014 Dec 18.

  PMID: 25521197 BACKGROUND

• Starritt EC, Joseph D, McKinnon JG, Lo SK, de Wilt JH, Thompson JF. Lymphedema after complete axillary node dissection for melanoma: assessment using a new, objective definition. Ann Surg. 2004 Nov;240(5):866-74. doi: 10.1097/01.sla.0000143271.32568.2b.

  PMID: 15492570 BACKGROUND

• Mehrara BJ, Zampell JC, Suami H, Chang DW. Surgical management of lymphedema: past, present, and future. Lymphat Res Biol. 2011;9(3):159-67. doi: 10.1089/lrb.2011.0011.

  PMID: 22066746 BACKGROUND

• Gomberawalla A, Feldman S. LYMPHA: New Innovation, Not Old Practice. J Clin Oncol. 2016 Sep 1;34(25):3108-9. doi: 10.1200/JCO.2016.67.8987. Epub 2016 Jun 13. No abstract available.

  PMID: 27298413 BACKGROUND

• van Akkooi AC, Bouwhuis MG, van Geel AN, Hoedemaker R, Verhoef C, Grunhagen DJ, Schmitz PI, Eggermont AM, de Wilt JH. Morbidity and prognosis after therapeutic lymph node dissections for malignant melanoma. Eur J Surg Oncol. 2007 Feb;33(1):102-8. doi: 10.1016/j.ejso.2006.10.032. Epub 2006 Dec 11.

  PMID: 17161577 BACKGROUND

• Brorson H, Hoijer P. Standardised measurements used to order compression garments can be used to calculate arm volumes to evaluate lymphoedema treatment. J Plast Surg Hand Surg. 2012 Dec;46(6):410-5. doi: 10.3109/2000656X.2012.714785.

  PMID: 23157502 BACKGROUND

• Boccardo FM, Casabona F, Friedman D, Puglisi M, De Cian F, Ansaldi F, Campisi C. Surgical prevention of arm lymphedema after breast cancer treatment. Ann Surg Oncol. 2011 Sep;18(9):2500-5. doi: 10.1245/s10434-011-1624-4. Epub 2011 Mar 3.

  PMID: 21369739 BACKGROUND

Study Officials

• Carolyn Nessim, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All melanoma and other skin cancers (merkel cell carcinoma, squamous cell carcinoma as well as sarcoma patients requiring a nodal dissection (groin or axillary) will be offered to have a LVA at time of nodal dissection to prevent lymphedema.

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 8, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 3, 2020
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)