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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 is a NA study that has completed, run by Our Lady of the Lake Hospital. The registered enrollment target is 38 participants.

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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.

Interventions

  • OTHER Observation
  • PROCEDURE Complete Decongestive Therapy

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-01-24
Est. Completion 2021-06-30
Phase NA

Sponsor

Our Lady of the Lake Hospital

4 total trials

What the Registry Record Tells You About NCT04045860

The ClinicalTrials.gov registry entry for NCT04045860 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Our Lady of the Lake Hospital, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Observation is the first listed.

NCT04045860 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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