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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: Completed Phase 4 study of Lymphedema, sponsored by Vanderbilt University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.

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

FieldValue
Enrollment Target 50 participants
Start Date 2009-09
Est. Completion 2012-04
Phase Phase 4
Vanderbilt University

430 total trials

What the finished NCT00852930 record still lists

NCT00852930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 9,298-participant average among 34 other Lymphedema trials with a reported enrollment target (99% lower).

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 a single indexed study location in 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.

Similar trials for Lymphedema

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00852930's enrollment target sits among peer trials

50 29th of 34 higher than 5 of 34 other Lymphedema trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lymphedema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00852930, the US trial registry maintained by the National Library of Medicine. NCT00852930 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.