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.
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| ClinicalTrials.gov Identifier: NCT01276054 |
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Recruitment Status :
Terminated
(P.I. left)
First Posted : January 13, 2011
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
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Sponsor:
University of Southern California
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California
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Brief 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 resectable stage 0-II breast cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphedema Recurrent Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer | 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 | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | October 2011 |
| Actual Study Completion Date : | October 2011 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Technetium Tc 99m Sulfur Colloid
| Arm | Intervention/treatment |
|---|---|
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Experimental: SNB plus ARM or ALND (+/- SNB) plus ARM
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.
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Radiation: technetium Tc 99m sulfur colloid
Given intradermally and periareolarly
Other Names:
Drug: methylene blue Given subcutaneously
Other Names:
Drug: indocyanine green solution Given subcutaneously
Other Names:
Procedure: sentinel lymph node biopsy Undergo sentinel lymph node biopsy
Other Name: sentinel node biopsy Procedure: axillary lymph node biopsy Undergo axillary lymph node biopsy
Other Name: axillary node biopsy Procedure: bioimpedance spectroscopy Correlative studies
Other Name: BIS Procedure: quality-of-life assessment Ancillary studies
Other Name: quality of life assessment Other: lymphedema management Undergo axillary reverse mapping |
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Active Comparator: SNB or ALND (+/- SNB)
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.
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Radiation: technetium Tc 99m sulfur colloid
Given intradermally and periareolarly
Other Names:
Drug: methylene blue Given subcutaneously
Other Names:
Drug: indocyanine green solution Given subcutaneously
Other Names:
Procedure: sentinel lymph node biopsy Undergo sentinel lymph node biopsy
Other Name: sentinel node biopsy Procedure: axillary lymph node biopsy Undergo axillary lymph node biopsy
Other Name: axillary node biopsy Procedure: bioimpedance spectroscopy Correlative studies
Other Name: BIS Procedure: quality-of-life assessment Ancillary studies
Other Name: quality of life assessment |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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): NCT01276054
Locations
| United States, California | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Dennis Holmes | University of Southern California |
| Responsible Party: | University of Southern California |
| ClinicalTrials.gov Identifier: | NCT01276054 |
| Other Study ID Numbers: |
1B-09-12 NCI-2010-02323 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
| First Posted: | January 13, 2011 Key Record Dates |
| Results First Posted: | August 1, 2014 |
| Last Update Posted: | August 1, 2014 |
| Last Verified: | February 2014 |
Additional relevant MeSH terms:
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Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Lymphatic Diseases |
Pharmaceutical Solutions Methylene Blue Technetium Tc 99m Sulfur Colloid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Radiopharmaceuticals |