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NCT00282529 · ClinicalTrials.gov registry record · NA
Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- NA
- Development phase
- 400
- Enrollment target
NCT00282529 is a NA study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 400 participants.
The verdict
NCT00282529, a NA study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
Study 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.
Interventions
- DEVICE High Risk Lymphedema Education and Device Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00282529
The ClinicalTrials.gov registry entry for NCT00282529 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which High Risk Lymphedema Education and Device Intervention is the first listed.
NCT00282529 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00282529 about?
NCT00282529 is a clinical study titled "Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study". 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 t...
What is the current status of trial NCT00282529?
This trial is currently terminated. It is a NA study. The enrollment target is 400 participants. The study started on 2006-01. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00282529?
The interventions under investigation include: High Risk Lymphedema Education and Device Intervention (DEVICE).
Who is sponsoring clinical trial NCT00282529?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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