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Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study

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ClinicalTrials.gov Identifier: NCT00282529
Recruitment Status : Terminated
First Posted : January 26, 2006
Last Update Posted : January 24, 2017
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE January 24, 2006
First Posted Date  ICMJE January 26, 2006
Last Update Posted Date January 24, 2017
Actual Study Start Date  ICMJE January 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2006)
Bilateral arm measurements, Lymphedema and Breast Cancer Questionnaire, Disability of the Arm and Shoulder and Hand(DASH)Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00282529 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2006)
Standard lymphedema risk reduction education, Lymphedema prevention
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 Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study
Official Title  ICMJE Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study
Brief Summary The proposed research is designed to establish lymphedema incidence rates for a varied population of breast cancer patients. Patients with breast preservation, mastectomy, sentinel lymph node biopsy, axillary dissection and radiation therapy will be included with the goal of determining the impact that each of these treatments has on development of lymphedema. Establishing incidence in these populations is crucial to the remainder of the study. We conduct a two phase study. The first phase will use arm measurements, a symptom survey (The Lymphedema and Breast Questionnaire), a functional survey (Disability of the Arm, Shoulder, and Hand Questionnaire), and operative and pathology information to create a simple screening tool to predict the development of lymphedema. Currently, lymphedema is only diagnosed after arm swelling develops. The goal of the screening tool is to identify those patients at significantly increased risk for development of lymphedema as compared to the general population of breast cancer survivors. Phase 2 of the study will test a lymphedema prevention strategy in a high risk population. The goal of this phase is to reduce the incidence of lymphedema in those patients that have undergone an axillary node dissection with radiation therapy by using a combination of education, a compression sleeve and decongestive exercises. If prevention is successful, the development of a screening tool becomes even more important to identify those patients that should undergo a prevention regimen.
Detailed Description

Background: Lymphedema has varied definitions, all based on limb volume changes. None incorporates limb volume changes, symptoms, and functional deficits. We will determine the incidence of lymphedema in breast cancer patients and the impact of breast conserving therapy, radiation therapy, sentinel lymph node biopsy, and axillary node dissection. The impact of lymphedema can be evaluated in a number of ways; 1) The Lymphedema and Breast Cancer Questionnaire (LBCQ) identifies symptoms that are unique to patients with lymphedema and 2) The Disability of the Arm, Hand, and Shoulder (DASH) survey will be used to determine the functional impact of lymphedema.

Objective/Hypothesis: Our hypotheses are: 1) Local therapies for breast cancer result in different lymphedema rates depending on the combination of therapies used. 2) A simple screening tool that incorporates symptoms, limb volume measurements, and tumor staging and treatment modalities can predict those patients that will develop lymphedema. 3) Functional impairment of the arm is severe in patients with lymphedema. 4) Prevention of lymphedema in a high risk population is possible with education, a compression sleeve, and decongestive exercise.

Specific Aims: 1) Evaluate patients both pre-operatively and at specific time intervals post-operatively to establish the incidence of lymphedema in sentinel lymph node biopsy and axillary dissection groups. 2) Create a simple screening tool using arm measurements, symptoms identified by the LBCQ, and treatment and staging information to identify patients that should go on to further testing and treatment. 3) Utilize the DASH survey to measure the extent of disability from lymphedema and surgical treatment. 4) Conduct a randomized trial of lymphedema prevention in a high-risk breast cancer population.

Study Design: This proposal will be conducted in two phases. Phase 1 will accomplish Specific Aim 1, 2, and 3. Patients with newly diagnosed breast cancer awaiting definitive surgery, will be enrolled pre-operatively and undergo arm measurements and complete the LBCQ and the DASH surveys. These same study procedures will be completed at 1, 3, 6, 12, 18, and 24 months postoperative. Documentation collected during the study will include: demographic information; co-morbid conditions; operative and pathology reports; and use of adjuvant therapies such as chemotherapy, hormonal therapy, and radiation therapy. Incidence rates of lymphedema and the impact of extent of surgery and radiation therapy will be determined. We will also use this information to develop a simple screening tool to identify patients that will develop lymphedema prior to the development of significant limb volume changes. Specific Aim 4 is Phase 2 of the proposal. A high risk population (those that have an axillary node dissection and radiation therapy) will be randomized to standard education versus standard education, compression sleeve, and exercise. The effectiveness of prevention to reduce incidence and severity of lymphedema and the impact on symptoms and functional impairment will be determined. This work will move toward a new paradigm of lymphedema management with a simple screening tool to identify high risk patients before significant swelling occurs and investigate prevention strategies to decrease the incidence of lymphedema.

Cancer Relevance: Lymphedema is a feared complication of breast cancer treatment. Currently it is recognized and treated only after development of significant limb volume changes when it is symptomatic and difficult to treat. Documentation of the impact of local therapies on the development of lymphedema will allow clinicians to make more informed decisions regarding risk benefit ratios of each of our local therapies. Development of a screening tool will allow us to identify high risk populations. Ideally, the high risk population will be identified and an effective prevention strategy implemented. Phase one of this study will help to answer the questions regarding incidence and create a screening tool and phase two will allow the evaluation of a prevention strategy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Breast Cancer
  • Lymphedema
Intervention  ICMJE Device: High Risk Lymphedema Education and Device Intervention
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: January 24, 2006)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Age of 18 years or older, biopsy proven breast cancer with no known metastatic cancer, surgical management of breast cancer with node evaluation to be completed at Johns Hopkins Hospital, ability to speak and read English, willing and able to continue follow-up at Johns Hopkins Avon foundation Breast Center -

Exclusion Criteria: Known psychiatric illness, unwillingness to be followed for two years, functional arm deficits, prior radiation therapy to the breast or axilla, any prior diagnosis of cancer except basal cell cancer

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282529
Other Study ID Numbers  ICMJE J05101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa Jacobs, M.D. Johns Hopkins Medical Institutions, Department of Surgery
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP