Complete Decongestive Therapy on Head and Neck Lymphedema

NCT04045860 | Completed

• 1 other identifier: CDT for HNL
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in composite facial measurements

  2 % percent change of composite facial measurement

  During inpatient stay, approximately 3-4 days

Study Arms (2)

CDT for head and neck lymphedema

EXPERIMENTAL

Complete Decongestive Therapy

Procedure: Complete Decongestive Therapy

Standard of Care for head and neck lymphedema

OTHER

Observation

Other: Observation

Interventions

Complete Decongestive Therapy PROCEDURE

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

CDT for head and neck lymphedema

Observation OTHER

Standard of care is currently observation

Standard of Care for head and neck lymphedema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years of age or older)
• Any head and neck cancer patient undergoing laryngectomy, neck dissection, maxillectomy or mandibulectomy
• Inpatient and referred for HNL treatment following surgery
• Patients with previous chemoradiation therapy or head and neck surgery accepted

You may not qualify if:

• Patients under the age of 18 years of age
• Patients who undergo neck dissection surgery that do not present with symptoms of HNL
• Patients with free tissue transfer reconstruction
• Unwilling or unable to consent

Sponsors & Collaborators

• Our Lady of the Lake Hospital: lead

Study Sites (1)

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Ashley Mays, MD

  Our Lady of the Lake

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double Blind randomization of patients and investigator outcome assessor. Patients that agree to participate will be randomized into a CDT treatment arm or a control arm that does not receive CDT. One speech pathologist on the study team will perform the CDT and will only be aware of the participant's cohort arm at the time of random assignment. The second speech pathologist will be blinded to the cohort arm and will be responsible for taking the cranio facial measurements for all participants to minimize investigator bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Research Director

Model Details: Randomized Control

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: January 24, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)