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NCT00577317 · ClinicalTrials.gov registry record · Phase 3
Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer
A Phase 3 study, sponsored by Gynecologic Oncology Group.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT00577317: Clinical Trial Phase 3 study, sponsored by Gynecologic Oncology Group.
NCT00577317 is a Phase 3 study that was terminated before completion, run by Gynecologic Oncology Group. The registered enrollment target is 2 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00577317, a Phase 3 study, was terminated before completion, sponsored by Gynecologic Oncology Group.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the Flexitouch® system is more effective than standard home maintenance therapy in treating lymphedema.
Primary Outcome
Volume for both lower extremities were going to be measured to determine if using the Flexi-touch was a more effective method to control lymphedema. Given that the study closed due to poor accrual (2 participants) analysis was not done.
Interventions
- OTHER Quality-of-Life Assessment
- PROCEDURE Management of Therapy Complications
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-07-27 |
| Phase | Phase 3 |
Why NCT00577317 stopped before completion
NCT00577317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Quality-of-Life Assessment is the first listed.
NCT00577317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00577317 about?
NCT00577317 is a clinical study titled "Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer". This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. Flexitouch® ho...
What is the current status of trial NCT00577317?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2007-12. Estimated completion is 2009-07-27.
What interventions are being tested in trial NCT00577317?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Management of Therapy Complications (PROCEDURE).
Who is sponsoring clinical trial NCT00577317?
This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00577317's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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