- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282529
Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore,, Maryland, United States, 21287
- Avon Breasts Center, Johns Hopkins Medical Institutions
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Bilateral arm measurements, Lymphedema and Breast Cancer Questionnaire, Disability of the Arm and Shoulder and Hand(DASH)Questionnaire
|
Secondary Outcome Measures
Outcome Measure |
---|
Standard lymphedema risk reduction education, Lymphedema prevention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisa Jacobs, M.D., Johns Hopkins Medical Institutions, Department of Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- J05101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
Clinical Trials on High Risk Lymphedema Education and Device Intervention
-
University of Wisconsin, MadisonCompleted
-
Henry Ford Health SystemAbiomed Inc.Recruiting
-
Ohio State University Comprehensive Cancer CenterCompletedMalignant Solid Neoplasm | Type 2 Diabetes Mellitus | Hematopoietic and Lymphoid System NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Heart, Lung, and Blood Institute should be included as a Collaborator...RecruitingObesity-Related Malignant NeoplasmUnited States
-
Heinrich-Heine University, DuesseldorfRecruitingPsychotic Disorders | PreventionGermany
-
Lawson Health Research InstituteRecruiting
-
University of UtahCenters for Disease Control and PreventionCompletedDiabetes Mellitus, Type 2 | PreDiabetesUnited States
-
Abbott Medical DevicesTerminated
-
Centre de recherche du Centre hospitalier universitaire...CompletedPotentially Inappropriate Medication Use
-
Roswell Park Cancer InstituteWithdrawnHead and Neck Squamous Cell CarcinomaUnited States