LymphedemaPhase 2NCT01276054
Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.
A Phase 2 study testing technetium Tc 99m sulfur colloid, methylene blue and indocyanine green solution in people with Lymphedema and Recurrent Breast Cancer, run by University of Southern California at 1 site in United States.
Trial summary
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Recurrent Breast Cancer, Stage IA Breast Cancer
- What is being tested?
- technetium Tc 99m sulfur colloid, methylene blue and indocyanine green solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 0, I, and II Breast Cancer
- Not pregnant or breastfeeding
- Breast cancer or prophylactic mastectomy requiring axillary nodal staging
- Ability to read and/or comprehend consent form and questionnaires
- Ability to follow-up per protocol
- Unilateral axillary staging
Who cannot join
- Stage 3
- Previous axillary lymph node dissection
- Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration
- Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may be used in these patients
- Patients with implanted medical devices such as a pacemaker may undergo perometry, but not BIS (Bioelectrical Impedance Spectroscopy)
- Previous diagnosis of LE (lymphedema) of either extremity
- Bilateral axillary staging
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer
Read the detailed description
PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who develop LE. II. To document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo and axillary reverse mapping. ARM II: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. After completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.
- Conditions
- Lymphedema, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Being tested
- technetium Tc 99m sulfur colloid, methylene blue, indocyanine green solution, sentinel lymph node biopsy, axillary lymph node biopsy
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
technetium Tc 99m sulfur colloidRadiation
Also called Tc 99m Sulfur Colloid, Tc-99m SC
Given intradermally and periareolarly
methylene blueDrug
Also called Azul de Metileno, Azul Metile, Blu di Metilene, MB
Given subcutaneously
indocyanine green solutionDrug
Also called IC-GREEN, ICG solution
Given subcutaneously
sentinel lymph node biopsyProcedure or surgery
Also called sentinel node biopsy
Undergo sentinel lymph node biopsy
axillary lymph node biopsyProcedure or surgery
Also called axillary node biopsy
Undergo axillary lymph node biopsy
bioimpedance spectroscopyProcedure or surgery
Also called BIS
Correlative studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
lymphedema managementOther
Undergo axillary reverse mapping
| Study group | Role | What they receive |
|---|---|---|
| SNB plus ARM or ALND (+/- SNB) plus ARM | Experimental | Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping. Receives: Radiation: technetium Tc 99m sulfur colloid; Drug: methylene blue; Drug: indocyanine green solution; Procedure: sentinel lymph node biopsy; Procedure: axillary lymph node biopsy; Procedure: bioimpedance spectroscopy; Procedure: quality-of-life assessment; Other: lymphedema management |
| SNB or ALND (+/- SNB) | Active comparator | Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Receives: Radiation: technetium Tc 99m sulfur colloid; Drug: methylene blue; Drug: indocyanine green solution; Procedure: sentinel lymph node biopsy; Procedure: axillary lymph node biopsy; Procedure: bioimpedance spectroscopy; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether or Not a Patient Has Developed Grade 1+ LE
LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.
Measured: During the first year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: P.I. left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphedemaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dennis Holmes, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276054
- Sponsor's protocol ID
- 1B-09-12
- Other IDs
- NCI-2010-02323
- Status last verified
- Feb 2014
- First submitted
- 11 Jan 2011
- Last updated
- 1 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program
- ClinicalTrials.gov ID
- NCT01276054
- Acronym / sponsor ID
- 1B-09-12
- Conditions
- Lymphedema, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: P.I. left
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 1 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who develop LE. II. To document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo and axillary reverse mapping. ARM II: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. After completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNB plus ARM or ALND (+/- SNB) plus ARM | Experimental | Radiation: technetium Tc 99m sulfur colloid, Drug: methylene blue, Drug: indocyanine green solution, Procedure: sentinel lymph node biopsy, Procedure: axillary lymph node biopsy, Procedure: bioimpedance spectroscopy, Procedure: quality-of-life assessment, Other: lymphedema managementPatients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping. |
| SNB or ALND (+/- SNB) | Active comparator | Radiation: technetium Tc 99m sulfur colloid, Drug: methylene blue, Drug: indocyanine green solution, Procedure: sentinel lymph node biopsy, Procedure: axillary lymph node biopsy, Procedure: bioimpedance spectroscopy, Procedure: quality-of-life assessmentPatients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage 0, I, and II Breast Cancer
- Not pregnant or breastfeeding
- Breast cancer or prophylactic mastectomy requiring axillary nodal staging
- Ability to read and/or comprehend consent form and questionnaires
- Ability to follow-up per protocol
Key exclusion criteria (7 listed)
- Stage 3
- Previous axillary lymph node dissection
- Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration
- Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may be used in these patients
- Patients with implanted medical devices such as a pacemaker may undergo perometry, but not BIS (Bioelectrical Impedance Spectroscopy)
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 |
|---|---|---|
| technetium Tc 99m sulfur colloidAlso: Tc 99m Sulfur Colloid, Tc-99m SCGiven intradermally and periareolarly | Radiation | SNB or ALND (+/- SNB), SNB plus ARM or ALND (+/- SNB) plus ARM |
| methylene blueAlso: Azul de Metileno, Azul Metile, Blu di Metilene, MBGiven subcutaneously | Drug | SNB or ALND (+/- SNB), SNB plus ARM or ALND (+/- SNB) plus ARM |
| indocyanine green solutionAlso: IC-GREEN, ICG solutionGiven subcutaneously | Drug | SNB or ALND (+/- SNB), SNB plus ARM or ALND (+/- SNB) plus ARM |
| sentinel lymph node biopsyAlso: sentinel node biopsyUndergo sentinel lymph node biopsy | Procedure or surgery | SNB or ALND (+/- SNB), SNB plus ARM or ALND (+/- SNB) plus ARM |
| axillary lymph node biopsyAlso: axillary node biopsyUndergo axillary lymph node biopsy | Procedure or surgery | SNB or ALND (+/- SNB), SNB plus ARM or ALND (+/- SNB) plus ARM |
| bioimpedance spectroscopyAlso: BISCorrelative studies | Procedure or surgery | SNB or ALND (+/- SNB), SNB plus ARM or ALND (+/- SNB) plus ARM |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | SNB or ALND (+/- SNB), SNB plus ARM or ALND (+/- SNB) plus ARM |
| lymphedema managementUndergo axillary reverse mapping | Other | SNB plus ARM or ALND (+/- SNB) plus ARM |
Primary outcome
Whether or Not a Patient Has Developed Grade 1+ LE
Time frame: During the first year post-operatively
LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dennis Holmes principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing technetium Tc 99m sulfur colloid, methylene blue and indocyanine green solution in people with Lymphedema and Recurrent Breast Cancer, run by University of Southern California at 1 site 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Whether or Not a Patient Has Developed Grade 1+ LE (time frame: During the first year post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2014.