Breast CancerNCT01273909
Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
An observational study of Breast Cancer and Hereditary Breast/Ovarian Cancer (brca1, brca2), run by The National Institute of Lymphology at 3 sites in United States.
Trial summary
The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Acquired Lymphedema
- What is being tested?
- Perforator Flap Breast Reconstruction and Vascularized Lymph Node Transfer
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2010to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects who are patients of the "Dr Marga" Practice or the Center for Restorative Breast Surgery that consent to participate in this research study will be selected. There is no age, ethnicity or gender requirement.
Who may be able to join
- Undergoing perforator flap surgery for breast reconstruction and/or vascularized lymph node transfer for treatment of lymphedema
Who cannot join
- Pregnant
- unable to read
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The DrMarga Practice Group
Charleston, South Carolina, 29403
National Institute of Lymphology
Chicago, Illinois, 60611
The Center for Restorative Breast Surgery
New Orleans, Louisiana, 70130
About this study
The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema.
The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.
Read the detailed description
Breast cancer is a serious health issue that affects 1 in 8 women. Although numerous treatments have arisen in recent years to aggressively combat this disease and increase survivorship, many survivors develop a crippling condition that can result in devastating physical and psychological impairments. Breast reconstruction by any method may help recovery psychologically. However, some individuals still report experiencing pain following their recovery from surgery. Additionally, secondary lymphedema is a common yet poorly understood complication of breast cancer patients. For those individuals who undergo axillary lymph node dissection the rates of incidence of lymphedema approach 47%. These rates tend to increase further for patients who receive irradiation treatment or mastectomies. Currently there is no known cure for lymphedema. Current treatments include non-invasive measures as well as surgical interventions. Vascularized lymph node transfer (VLNTx) is a fairly recent surgical procedure that has shown promising results.
The goal of this research study is to analyze the clinical outcome of subjects who undergo breast reconstruction with perforator flaps and/or VLNTx using information collected as part of standard care.
Clinical data will be collected prospectively. All subjects who undergo a surgical procedure will complete the online persistent postsurgical pain assessment questionnaire.
The BreastQ questionnaire will be completed by patients prior to and after undergoing breast reconstruction and/or lymphedema treatment.
- Conditions
- Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Acquired Lymphedema, Congenital Lymphedema
- Being tested
- Perforator Flap Breast Reconstruction, Vascularized Lymph Node Transfer
- Keywords
- Breast Cancer, BRACA1/2 Genotype, Acquired Lymphedema, Congenital Lymphedema
- Medical subject headings
- Breast Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perforator Flap Breast ReconstructionProcedure or surgery
Also called DIEP Flap, SGAP Flap, IGAP Flap, SIEA Flap
perforator flap breast reconstruction with or without vascularized lymph node transfer
Vascularized Lymph Node TransferProcedure or surgery
Also called VLNTx
perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Perforator Flap Breast Reconstruction | Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer Receives: Procedure: Perforator Flap Breast Reconstruction; Procedure: Vascularized Lymph Node Transfer | |
| Vascularized Lymph Node Transfer | Patients who undergo perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction Receives: Procedure: Perforator Flap Breast Reconstruction; Procedure: Vascularized Lymph Node Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BreastQ Questionnaire and Lymphedema Severity Score
Measured: Baseline and 6 months after surgery
Secondary outcomes (1)
Persistent Postsurgical Pain assessment questionnaire
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJul 2010
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Institute of Lymphology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The DrMarga Practice Group, The Center for Restorative Breast Surgery, LLC
- Responsible party
- Principal investigator, Marga F. Massey, M.D., The National Institute of Lymphology
- Investigators
- Marga F. Massey, M.D., Principal investigator, National Institute of Lymphology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273909
- Sponsor's protocol ID
- MFM001
- Other IDs
- 1116697
- Status last verified
- Jun 2014
- First submitted
- 7 Jan 2011
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Massey MF, Spiegel AJ, Levine JL, Craigie JE, Kline RM, Khoobehi K, Erhard H, Greenspun DT, Allen RJ Jr, Allen RJ Sr; Group for the Advancement of Breast Reconstruction. Perforator flaps: recent experience, current trends, and future directions based on 3974 microsurgical breast reconstructions. Plast Reconstr Surg. 2009 Sep;124(3):737-751. doi: 10.1097/PRS.0b013e3181b17a56.
PubMed 19730293Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
PubMed 19903919Dayangac M, Makay O, Yeniay L, Aynaci M, Kapkac M, Yilmaz R. Precipitating factors for lymphedema following surgical treatment of breast cancer: implications for patients undergoing axillary lymph node dissection. Breast J. 2009 Mar-Apr;15(2):210-1. doi: 10.1111/j.1524-4741.2009.00703.x. No abstract available.
PubMed 19292814Becker C, Assouad J, Riquet M, Hidden G. Postmastectomy lymphedema: long-term results following microsurgical lymph node transplantation. Ann Surg. 2006 Mar;243(3):313-5. doi: 10.1097/01.sla.0000201258.10304.16.
PubMed 16495693Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014.
PubMed 18519968
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
- ClinicalTrials.gov ID
- NCT01273909
- Acronym / sponsor ID
- MFM001
- Conditions
- Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Acquired Lymphedema, Congenital Lymphedema
- Keywords
- Breast Cancer, BRACA1/2 Genotype, Acquired Lymphedema, Congenital Lymphedema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The National Institute of LymphologyIndustry (pharma, biotech, devices)
- Collaborators
- The DrMarga Practice Group, The Center for Restorative Breast Surgery, LLC
- Study start
- Jul 2010
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema.
The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.
Detailed description
Breast cancer is a serious health issue that affects 1 in 8 women. Although numerous treatments have arisen in recent years to aggressively combat this disease and increase survivorship, many survivors develop a crippling condition that can result in devastating physical and psychological impairments. Breast reconstruction by any method may help recovery psychologically. However, some individuals still report experiencing pain following their recovery from surgery. Additionally, secondary lymphedema is a common yet poorly understood complication of breast cancer patients. For those individuals who undergo axillary lymph node dissection the rates of incidence of lymphedema approach 47%. These rates tend to increase further for patients who receive irradiation treatment or mastectomies. Currently there is no known cure for lymphedema. Current treatments include non-invasive measures as well as surgical interventions. Vascularized lymph node transfer (VLNTx) is a fairly recent surgical procedure that has shown promising results.
The goal of this research study is to analyze the clinical outcome of subjects who undergo breast reconstruction with perforator flaps and/or VLNTx using information collected as part of standard care.
Clinical data will be collected prospectively. All subjects who undergo a surgical procedure will complete the online persistent postsurgical pain assessment questionnaire.
The BreastQ questionnaire will be completed by patients prior to and after undergoing breast reconstruction and/or lymphedema treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perforator Flap Breast Reconstruction | – | Procedure: Perforator Flap Breast Reconstruction, Procedure: Vascularized Lymph Node TransferPatients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer |
| Vascularized Lymph Node Transfer | – | Procedure: Perforator Flap Breast Reconstruction, Procedure: Vascularized Lymph Node TransferPatients who undergo perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who are patients of the "Dr Marga" Practice or the Center for Restorative Breast Surgery that consent to participate in this research study will be selected. There is no age, ethnicity or gender requirement.
Key inclusion criteria (1 listed)
- Undergoing perforator flap surgery for breast reconstruction and/or vascularized lymph node transfer for treatment of lymphedema
Key exclusion criteria (2 listed)
- Pregnant
- unable to read
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perforator Flap Breast ReconstructionAlso: DIEP Flap, SGAP Flap, IGAP Flap, SIEA Flapperforator flap breast reconstruction with or without vascularized lymph node transfer | Procedure or surgery | Perforator Flap Breast Reconstruction, Vascularized Lymph Node Transfer |
| Vascularized Lymph Node TransferAlso: VLNTxperforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction | Procedure or surgery | Perforator Flap Breast Reconstruction, Vascularized Lymph Node Transfer |
Primary outcome
Change in BreastQ Questionnaire and Lymphedema Severity Score
Time frame: Baseline and 6 months after surgery
1 secondary outcome
Persistent Postsurgical Pain assessment questionnaire
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Background: PubMed 19730293Massey MF, Spiegel AJ, Levine JL, Craigie JE, Kline RM, Khoobehi K, Erhard H, Greenspun DT, Allen RJ Jr, Allen RJ Sr; Group for the Advancement of Breast Reconstruction. Perforator flaps: recent experience, current trends, and future directions based on 3974 microsurgical breast reconstructions. Plast Reconstr Surg. 2009 Sep;124(3):737-751. doi: 10.1097/PRS.0b013e3181b17a56.
- Background: PubMed 19903919Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
- Background: PubMed 19292814Dayangac M, Makay O, Yeniay L, Aynaci M, Kapkac M, Yilmaz R. Precipitating factors for lymphedema following surgical treatment of breast cancer: implications for patients undergoing axillary lymph node dissection. Breast J. 2009 Mar-Apr;15(2):210-1. doi: 10.1111/j.1524-4741.2009.00703.x. No abstract available.
- Background: PubMed 16495693Becker C, Assouad J, Riquet M, Hidden G. Postmastectomy lymphedema: long-term results following microsurgical lymph node transplantation. Ann Surg. 2006 Mar;243(3):313-5. doi: 10.1097/01.sla.0000201258.10304.16.
- Background: PubMed 18519968Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014.
- National Institute of Lymphology research web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marga F. Massey, M.D. principal investigator
National Institute of Lymphology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Hereditary Breast/Ovarian Cancer (brca1, brca2), run by The National Institute of Lymphology at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BreastQ Questionnaire and Lymphedema Severity Score (time frame: Baseline and 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01273909, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.