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Clinical Trials/NCT04045860
NCT04045860CompletedNot Applicable

The Effects of Complete Decongestive Therapy on Head and Neck Lymphedema in Post-surgical Head and Neck Cancer Patients (Randomized Control Trial)

Our Lady of the Lake Hospital2 sites in 1 country38 target enrollmentStarted: January 24, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
38
Locations
2
Primary Endpoint
Change in composite facial measurements

Study Overview

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.

Detailed Description

BACKGROUND:

Head and neck lymphedema (HNL) is a common and sometimes debilitating complication of head and neck cancer (HNC) treatment. It occurs when the lymphatic system is either overloaded or damaged and cannot clear the high protein lymphatic fluid within the interstitial tissues. This in turn causes inflammation, connective tissue proliferation and overall functional impairment of the lymph system and bodily extremities. The long-term effects that edema can have in the cranio-facial region are not simply a cosmetic nuisance, but can lead to severe functional and psycho-social issues when affecting the lips, tongue, throat, eyes, mouth and neck. The ability to communicate, swallow, breath and see can be greatly impeded by the lymphatic swelling, which clearly affects the quality of life for many patients. Additional deficits may include dysfunction of the arms and shoulders with reduced cervical range of motion. Although lymphedema is well recognized in patients within the fields of urinary, breast and gynecologic cancer, it has only recently been addressed in the area of head and neck cancer.

The therapeutic management of HNL in HNC patients is a growing topic of research, as this condition pushes to the forefront and crosses over multi-disciplinary departments from otolaryngology to cancer therapy to speech and language therapy and rehabilitation. Historically, the technique of manual lymph drainage (MLD), a series of gentle circular massage strokes applied to the skin to increase lymphatic flow has been used. Decades later, the MLD technique was combined with compression bandaging, physical exercises and a skin care regiment to create a complete decongestive therapy (CDT) in the outpatient setting and is now considered to be best practice for outpatient lymphedema treatment at some institutions. The HNL program at M.D. Anderson Cancer Center has also created a series of formal evaluation and treatment techniques which include patient interviews/survey, visual assessment of the cranio-facial, neck and shoulder areas, functional assessments of communication and swallowing, photography, tape measurements and staging scales of edema to characterize the appearance and severity of the swelling.

Herein, investigators propose to examine the effects of complete decongestive therapy on head and neck cancer patients at Our Lady of the Lake Regional Medical Center who experience post-surgical head and neck lymphedema after total laryngectomy, neck dissection, maxillectomy or mandibulectomy compared to a control cohort. Investigators aim to assess the improvement of patient outcomes through the use of this technique to reduce cranio-facial edema and compare to those who do not receive CDT in an in-patient setting. Our study is novel in that there is minimal data on the effect of CDT in the acute care setting and in the areas of the head and neck, hence contributing to the growing body of knowledge about this therapy in this acute patient population.

OBJECTIVES:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in composite facial measurements

Time Frame: During inpatient stay, approximately 3-4 days

2 % percent change of composite facial measurement

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Our Lady of the Lake Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leslie Son

Academic Research Director

Our Lady of the Lake Hospital

Study Sites (2)

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