A Study to Determine the Effects of a Mechanical Device to Treat Swelling of the Face and Neck Following Treatment for Cancer.
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-003342
About this study
This study aims to assess the utility of pharyngeal manometry measures as a novel approach in quantifying internal lymphedema and compare success rates in reducing internal lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). It also aims to assess efficacy of PCD and MLD and assess compliance of treatment in both groups. Lastly, it aims to identify voice and swallowing changes in both groups.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent.
- Cognitive function adequate to understand and execute the elements of the protocol.
- Willingness and ability to return to Mayo Clinic for follow-up care per protocol.
- Resolution of acute toxicities from CRT.
Exclusion Criteria:
- Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer.
- Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative.
- Acute facial infection.
- Active CHF or pulmonary edema.
- Symptomatic carotid artery disease or bradycardia.
- Increased intracranial pressure.
- History of multiple CVAs or TIAs.
- > 50% ICA blockage.
- Upper quadrant deep vein thrombosis.
- No known esophageal obstruction.
- Women of Child Bearing Potential.
- (Active) pregnancy
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Lisa Crujido, CCC-SLP |
Closed-enrolling by invitation |
Contact information:
Lisa Crujido CCC-SLP
Crujido.Lisa@mayo.edu
|
More information
Publications
Publications are currently not available