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出境医 / 临床实验 / An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction
An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction
Study Description
Brief Summary:
This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Carcinoma | Procedure: Mammoplasty Procedure: Vascularized Lymph Node Transfer | Not Applicable |
Detailed Description:
PRIMARY OBJECTIVE:
I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction.
SECONDARY OBJECTIVES:
I. Determine the overall complications of prophylactic vascularized lymph node transfers.
II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer.
OUTLINE:
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
After completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 25 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous Breast Reconstruction |
| Actual Study Start Date : | May 24, 2019 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment (vascularized lymph node transfer)
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
|
Procedure: Mammoplasty
Undergo standard of care breast reconstructive surgery
Other Name: Breast Reconstruction
Procedure: Vascularized Lymph Node Transfer Undergo vascularized lymph node transfer
Other Name: VLNT
|
Outcome Measures
Primary Outcome Measures :
- Incidence rate of lymphedema development [ Time Frame: At 12 months after surgery ]Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated.
- Time to lymphedema development [ Time Frame: Up to 2 years ]Will be estimated by the Kaplan-Meier method.
Secondary Outcome Measures :
- Incidence rate of lymphedema development [ Time Frame: Up to 2 years ]The incidence of lymphedema between patients who undergo vascularized lymph node transfer (VLNT) and historical cohorts who do not will be compared. The inverse probability of treatment weighting using the propensity scores will be applied to estimate the effect of VLNT.
- Complications of prophylactic VLNT [ Time Frame: Within 30 days after surgery ]Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction
Exclusion Criteria:
- Patients that are known to be pregnant at the time of surgery
- Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)
Contacts and Locations
Contacts
| Contact: Edward I. Chang | 713-794-1247 | eichang@mdanderson.org |
Locations
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Edward I. Chang 713-794-1247 eichang@mdanderson.org | |
| Principal Investigator: Edward I. Chang | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Edward I Chang | M.D. Anderson Cancer Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 17, 2019 | ||||
| First Posted Date ICMJE | June 19, 2019 | ||||
| Last Update Posted Date | November 9, 2020 | ||||
| Actual Study Start Date ICMJE | May 24, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction | ||||
| Official Title ICMJE | Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous Breast Reconstruction | ||||
| Brief Summary | This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction. | ||||
| Detailed Description |
PRIMARY OBJECTIVE: I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction. SECONDARY OBJECTIVES: I. Determine the overall complications of prophylactic vascularized lymph node transfers. II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer. OUTLINE: Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery. After completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Breast Carcinoma | ||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: Treatment (vascularized lymph node transfer)
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
25 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03990610 | ||||
| Other Study ID Numbers ICMJE | 2018-0528 NCI-2019-03182 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0528 ( Other Identifier: M D Anderson Cancer Center ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| PRS Account | M.D. Anderson Cancer Center | ||||
| Verification Date | November 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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