Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection
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| ClinicalTrials.gov Identifier: NCT04241341 |
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Recruitment Status :
Recruiting
First Posted : January 27, 2020
Last Update Posted : June 28, 2022
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Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
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Brief Summary:
The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include:
Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of lymphedema
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Lymphedema | Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction Other: quality-of-life questionnaires Other: measured by arm volume | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 174 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Patients will be randomized to one of two groups: ALND with ILR (intervention group) and ALND without ILR (control group; current standard treatment at Memorial Sloan Kettering [MSK]). |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection |
| Actual Study Start Date : | January 22, 2020 |
| Estimated Primary Completion Date : | January 2023 |
| Estimated Study Completion Date : | January 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: axillary lymph node dissection with ILR |
Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction Other: quality-of-life questionnaires Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. Other: measured by arm volume Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula. |
| Active Comparator: axillary lymph node dissection (ALND) without ILR |
Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction
Current standard treatment at Memorial Sloan Kettering [MSK]). Other: quality-of-life questionnaires Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. Other: measured by arm volume Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula. |
Primary Outcome Measures :
- the number of patients that had a decrease incidence of lymphedema [ Time Frame: 2 years ]as measured by arm volume will be a ≥10% increase in arm volume
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Breast Cancer |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female breast cancer patients 18-75 years of age
- Patients consenting for unilateral ALND (prior history of SLNBx allowed if <6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon
- Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery
Exclusion Criteria:
- Male breast cancer patients
- Non-English speaking participants
- Female breast cancer patients with axillary recurrence
- Female breast cancer patients who have a history of ALND
- Female patients requiring bilateral ALND for the treatment of their breast cancer
- Female breast patients treated with SLNBx only
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241341
Contacts
| Contact: Michelle Coriddi, MD | 646-608-8042 | coriddim@mskcc.org | |
| Contact: Babak Mehrara, MD | 212-639-3099 |
Locations
| United States, New Jersey | |
| Memorial Sloan Kettering Basking Ridge (Consent and Followup) | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: Michelle Coriddi, MD 646-608-8042 | |
| Memorial Sloan Kettering Monmouth (Consent Only) | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Michelle Coriddi, MD 646-608-8042 | |
| Memorial Sloan Kettering Bergen (Consent Only) | Recruiting |
| Montvale, New Jersey, United States, 07645 | |
| Contact: Michelle Coriddi, MD 646-608-8042 | |
| United States, New York | |
| Memorial Sloan Kettering Commack (Consent only) | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Michelle Coriddi, MD 646-608-8042 | |
| Memorial Sloan Kettering Westchester (Consent Only) | Recruiting |
| Harrison, New York, United States, 10604 | |
| Contact: Michelle Coriddi, MD 646-608-8042 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Michelle Coriddi, MD 646-608-8042 | |
| Memorial Sloan Kettering Nassau (Consent only) | Recruiting |
| Uniondale, New York, United States, 11553 | |
| Contact: Michelle Coriddi, MD 646-608-8042 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Michelle Coriddi, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT04241341 |
| Other Study ID Numbers: |
20-021 |
| First Posted: | January 27, 2020 Key Record Dates |
| Last Update Posted: | June 28, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org. |
| 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:
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Axillary Lymph Node Dissection Lymphatic Reconstruction 20-021 |
Additional relevant MeSH terms:
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Lymphedema Breast Cancer Lymphedema Lymphatic Diseases Postoperative Complications Pathologic Processes |