Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04045860 |
| Other study ID # |
CDT for HNL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 24, 2019 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Our Lady of the Lake Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
The objective of of this research study is to assess physical improvements in visual,
measureable and functional outcomes in head and neck cancer patients with head and neck
lymphedema who have undergone Complete Decongestive Therapy (CDT) as a part of in-patient
care at Our Lady of the Lake Hospital and compare this to patients in a control group who do
not receive CDT.
STUDY DESIGN:
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 and have been referred by their physician for
evaluation of head and neck lymphedema while admitted to inpatient care at Our Lady of the
Lake Regional Medical Center following surgery. 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. Specific therapies for speech
and language performance are provided beginning 24-72 hours post op per standard of care. At
the time of speech therapy, patients will be informed and consented at the hospital bedside
about this study. Those that agree to participate will be randomized into a CDT treatment arm
or a control arm. The CDT therapy arm will be a combination of manual lymph drainage (MLD),
tissue compression or kinesio tape bandaging, remedial exercises and a skin care regiment.
This therapy will be administered every time the patient is seen by the speech pathologist,
which is typically on a daily basis until discharge. Patients who are randomized into the
control arm will not receive the specific CDT, but will still receive any speech or language
therapy or other medical treatment services that are standard for their care management plan.
Cranio-facial measurements will be taken of both cohorts by a blinded measurer prior to
therapy and prior to hospital discharge, after several rounds of CDT have been administered
to the patient. Those in the non-CDT cohort will be measured at the day of inpatient consult
and again on day of discharge. Changes in the measurements will determine if the CDT has a
positive effect on the edema symptoms.
One speech pathologist on the study team will perform the CDT or control therapy and will
only be aware of the participant's cohort arm at the time of random assignment. A second
speech pathologist will be blinded to the cohort arm and will be responsible for taking the
cranio facial measurements for all participants.
Patients will be randomized into one of two groups. Group A will receive the CDT during their
inpatient stay. Group B will not receive the CDT. The randomization of the patients into
these 2 cohorts will be predetermined by pulling 15 permuted blocks of 4 (Ex. AABB, ABAB,
BABB, ABBA, etc) pre-drawn by an individual not involved in the therapy. The permuted blocks
will be lined up sequentially (Ex. AABBABABBABBABBA…..) and each letter placed in one of 60
envelopes. The speech pathologist assigned to the patient will pull the next envelope in
order to determine if the patient will be in Group A (CDT) or Group B (no CDT) post-surgery.
The principal investigator and the individual who will perform the measurements will be
completely blinded to the patient's cohort assignment and in this way, minimize investigator
bias.
A medical chart review will also be conducted to gather additional variables such as age,
gender, race and any prior head and neck cancer medical history.
