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Complete Decongestive Therapy on Head and Neck Lymphedema

NCT04045860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-09-08

No results posted yet for this 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.

Conditions

  • Lymphedema of Face
  • Secondary Lymphedema

Interventions

PROCEDURE

Complete Decongestive Therapy

A combination of manual lymph drainage , compression bandaging, physical exercise and a skin care regimen

OTHER

Observation

Standard of care is currently observation

Sponsors & Collaborators

  • Our Lady of the Lake Hospital

    lead OTHER

Principal Investigators

  • Ashley Mays, MD · Our Lady of the Lake

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2020-12-31
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045860 on ClinicalTrials.gov