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NCT00852930 · ClinicalTrials.gov registry record · Phase 4
Low Level Laser Treatment and Breast Cancer Related Lymphedema
A Phase 4 study of Lymphedema, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00852930 is a Phase 4 study of Lymphedema that has completed, run by Vanderbilt University. The registered enrollment target is 50 participants, below the 9,298-participant average among 34 other Lymphedema trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00852930, a Phase 4 study of Lymphedema, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the arm) is the current standard of treatment for breast cancer related lymphedema (arm swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT has possible value in the treatment of lymphedema and warrants subsequent evaluation in a larger study.
Conditions Studied
Interventions
- PROCEDURE laser and MLD combined
- PROCEDURE laser alone
- PROCEDURE manual lymphatic drainage
Study Locations (1)
Tennessee
- Vanderbilt University School of Nursing - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00852930
The ClinicalTrials.gov registry entry for NCT00852930 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,298-participant average among 34 other Lymphedema trials with a reported enrollment target (99% lower). The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lymphedema appearing as the primary indexed condition, and to 3 interventions - of which laser and MLD combined is the first listed.
NCT00852930 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT00852930 about?
NCT00852930 is a clinical study titled "Low Level Laser Treatment and Breast Cancer Related Lymphedema". Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the arm) is the current standard of treatment for breast cancer related lymphedema (arm swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional and self/home treatment of lymphe...
What is the current status of trial NCT00852930?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2009-09. Estimated completion is 2012-04.
What conditions does trial NCT00852930 study?
This clinical trial studies the following conditions: Lymphedema.
What interventions are being tested in trial NCT00852930?
The interventions under investigation include: laser and MLD combined (PROCEDURE), laser alone (PROCEDURE), manual lymphatic drainage (PROCEDURE).
Who is sponsoring clinical trial NCT00852930?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00852930 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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