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NCT04045860 · ClinicalTrials.gov registry record · NA
Complete Decongestive Therapy on Head and Neck Lymphedema
A NA study, sponsored by Our Lady of the Lake Hospital.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT04045860: Completed NA study, sponsored by Our Lady of the Lake Hospital.
NCT04045860 is a NA study that has completed, run by Our Lady of the Lake Hospital. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04045860, a NA study, has completed, sponsored by Our Lady of the Lake Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
This will be a prospective, randomized controlled study of \~60 adult patients who have undergone a laryngectomy, neck dissection, maxillectomy or mandibulectomy surgical procedure for the treatment of head and neck cancer at Our Lady of the Lake Hospital and have been referred by their physician for evaluation of head and neck lymphedema while serving as an inpatient. Consenting patients will be evaluated by certified speech and language pathologists trained to ascertain lymphedema severity using a series of visual and tangible measurements immediately following surgery and randomized into two cohorts, one receiving the complete decongestive therapy regimen and the other not receiving this specific combination treatment for their edema. Facial and neck measurements will be taken at baseline following surgery and at several points prior to and at discharge as well as at the 2 week follow up visit to the clinic. Measurements and overall change/reduction in edema will be compared between the cohorts.
Primary Outcome
2 % percent change of composite facial measurement
Interventions
- OTHER Observation
- PROCEDURE Complete Decongestive Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
What the finished NCT04045860 record still lists
NCT04045860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Observation is the first listed.
NCT04045860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04045860 about?
NCT04045860 is a clinical study titled "Complete Decongestive Therapy on Head and Neck Lymphedema". This will be a prospective, randomized controlled study of \~60 adult patients who have undergone a laryngectomy, neck dissection, maxillectomy or mandibulectomy surgical procedure for the treatment of head and neck cancer at Our Lady of the Lake Hospital and have been referred by their physician fo...
What is the current status of trial NCT04045860?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2019-01-24. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT04045860?
The interventions under investigation include: Observation (OTHER), Complete Decongestive Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT04045860?
This trial is sponsored by Our Lady of the Lake Hospital, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04045860's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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