A Study to Determine the Effects of a Mechanical Device to Treat Swelling of the Face and Neck Following Treatment for Cancer.

Overview

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 What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Lisa Crujido CCC-SLP Crujido.Lisa@mayo.edu

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

Clinical Trials