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NCT00880022 · ClinicalTrials.gov registry record · NA
Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 47
- Enrollment target
NCT00880022 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 47 participants.
The verdict
NCT00880022, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
Study Summary
No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy for arm lymphedema. Hypotheses: Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical impedance \& arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System. H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with the Flexitouch® System. H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after 10 sessions with the Flexitouch® System. H4: Functional assessment scores (as measured by the Functional Assessment Screening Questionnaire \[FASQ\] will improve after 10 sessions with the Flexitouch® System. Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance \& arm girth in cm) will be significantly reduced after one month of home use in participants using the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only). H2: Truncal measurements/volume (as measured circumferentially) will be less after one month of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only). H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by Lymphedema Symptom Intensity and Distress Scal
Interventions
- DEVICE Flexitouch System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2009-05 |
| Est. Completion | 2010-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00880022
The ClinicalTrials.gov registry entry for NCT00880022 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Flexitouch System is the first listed.
NCT00880022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00880022 about?
NCT00880022 is a clinical study titled "Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer". No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals who have only limb lym...
What is the current status of trial NCT00880022?
This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2009-05. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00880022?
The interventions under investigation include: Flexitouch System (DEVICE).
Who is sponsoring clinical trial NCT00880022?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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