Lymphedema Management for human papillomavirus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Arizona, Scottsdale, AZ
human papillomavirus+24 More
Lymphedema Management - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Lymphedema can be the result of surgery, radiation therapy, chemotherapy or any combination of these procedures. Internal lymphedema has been shown to negatively affect speech production, swallowing, respiration, and voice. Flexitouch is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides pressure changes to move lymph fluid from the impaired area toward healthy regions of the body. Complete decongestive therapy (CDT) is standard of care for treating external lymphedema and involves manual lymphatic drainage (MLD) performed by licensed therapists followed by compression therapy. CDT has long been used for treating lymphedema of the limbs. Combining a pneumatic compression system with standard of care manual lymphatic drainage may have positive effects on speech, voice, and swallowing.

Eligible Conditions

  • human papillomavirus
  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Head and Neck Carcinoma
  • Malignant neoplasm of larynx
  • Carcinoma
  • Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Malignant Neoplasms
  • Stage II Hypopharyngeal Carcinoma AJCC v8
  • Stage III Hypopharyngeal Carcinoma AJCC v8
  • Stage III Lip and Oral Cavity Cancer AJCC v8
  • Stage IV Hypopharyngeal Carcinoma AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 12 weeks

Week 12
Compare composite measurements of the face and neck for lymphatic drainage
Up to 12 weeks
Change in lymphedema of the head and neck
Improvements on quality of life (QOL) function
Improvements on swallowing function
Improvements on voice function

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Group II (standard of care, lymphedema management)
1 of 2
Group I (pneumatic therapy, lymphedema management)
1 of 2
Active Control
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Lymphedema Management · No Placebo Group · N/A

Group I (pneumatic therapy, lymphedema management)Experimental Group · 9 Interventions: Quality-of-Life Assessment, Questionnaire Administration, Consensus Auditory-Perceptual Evaluation of Voice, Lymphedema Management, Modified Barium Swallow, Pneumatic Compression Therapy, Voice Handicap Index-10, Diagnostic Imaging, Nasopharyngeal Laryngoscopy · Intervention Types: Other, Other, Other, Other, Procedure, Device, Other, Procedure, Procedure
Group II (standard of care, lymphedema management)ActiveComparator Group · 9 Interventions: Quality-of-Life Assessment, Questionnaire Administration, Consensus Auditory-Perceptual Evaluation of Voice, Lymphedema Management, Modified Barium Swallow, Voice Handicap Index-10, Diagnostic Imaging, Nasopharyngeal Laryngoscopy, Best Practice · Intervention Types: Other, Other, Other, Other, Procedure, Other, Procedure, Procedure, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 weeks
Closest Location: Mayo Clinic in Arizona · Scottsdale, AZ
Photo of Scottsdale 1Photo of Scottsdale 2Photo of Scottsdale 3
2011First Recorded Clinical Trial
0 TrialsResearching human papillomavirus
225 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,440 Total Patients Enrolled
Mayo ClinicLead Sponsor
2,860 Previous Clinical Trials
3,686,141 Total Patients Enrolled
Lisa CrujidoPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to return to Mayo Clinic for follow-up care per protocol.
You must demonstrate oropharyngeal competency that would allow some oral intake.
You have a history of chemoradiotherapy (CRT) for malignant skin cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.