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A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03248310
Collaborator
(none)
300
Enrollment
2
Locations
71.7
Anticipated Duration (Months)
150
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Quality of Life Assessments

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
Actual Study Start Date :
Aug 9, 2017
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
vascularized lymph node transfer (VLNT)

This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.

Behavioral: Quality of Life Assessments
Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
non-surgical treatment

This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.

Behavioral: Quality of Life Assessments
Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life [up to 40 months]

    Questionnaire to assess quality of life changes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

  • Patients aged 18-80 years

  • Primary and secondary lymphedema of the upper or lower extremity

  • International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema

  • BMI <40

  • Proficiency in English language

Exclusion Criteria:

  • Patients with clotting disorders, venous insufficiency, end-stage lymphedema

  • Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Westchester (Consent only) Harrison New York United States 10604
2 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Joseph Dayan, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT03248310
Other Study ID Numbers:
  • 17-377
First Posted:
Aug 14, 2017
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Quality of Life (QoL)
17-377
Additional relevant MeSH terms:
Lymphedema

Study Results

No Results Posted as of Jul 15, 2022