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Lymphedema Management for Oropharyngeal Carcinoma

N/A
Waitlist Available
Led By Lisa Crujido
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

This trial is testing whether adding a pneumatic compression system to manual lymphatic drainage improves treatment of patients with lymphedema after chemoradiation for head and neck cancer.

Eligible Conditions
  • Oropharyngeal Carcinoma
  • Lip and Oral Cavity Cancer
  • Laryngeal Cancer
  • Hypopharyngeal Cancer
  • Head and Neck Cancers

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in lymphedema of the head and neck
Compare composite measurements of the face and neck for lymphatic drainage
Secondary outcome measures
Improvements on quality of life (QOL) function
Deglutition
Improvements on voice function

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (pneumatic therapy, lymphedema management)Experimental Treatment9 Interventions
Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.
Group II: Group II (standard of care, lymphedema management)Active Control9 Interventions
Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,177 Previous Clinical Trials
3,758,361 Total Patients Enrolled
1 Trials studying Oropharyngeal Carcinoma
117 Patients Enrolled for Oropharyngeal Carcinoma
National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,918,305 Total Patients Enrolled
2 Trials studying Oropharyngeal Carcinoma
132 Patients Enrolled for Oropharyngeal Carcinoma
Lisa CrujidoPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently openings for people to participate in this experiment?

"This particular medical study is no longer in the recruitment phase and has not been since August 23rd, 2022. However, there are 2,899 other clinical trials that are currently seeking participants on clinicaltrials.gov."

Answered by AI
~0 spots leftby Mar 2025