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CDT Management for Head and Neck Cancer-Related Lymphedema

N/A
Recruiting
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Diagnosis of head and neck lymphedema and referral by oncology providers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after end of intervention (an average of 6 weeks), 6-month post-intervention, 12-month post-intervention
Awards & highlights

Study Summary

This trial will compare two different treatments for cancer-related lymphedema - one given in a clinic setting and one given at home. They will compare how well each treatment works, based on measures of lymphedema severity, symptoms, functional status, and healthcare utilization.

Who is the study for?
This trial is for adults over 18 who have head and neck lymphedema within 24 months after cancer treatment. They must be referred by their oncology providers, able to do self-manual lymph drainage, and have internet access plus a digital device at home. It's not for those with active infections in the area, carotid artery disease, or very severe lymphedema.Check my eligibility
What is being tested?
The study compares two treatments for managing lymphedema: one where patients go to a clinic (Clinic-based CDT) and another they can do at home using a hybrid model (Home-based CDT). The goal is to see which method better reduces swelling severity, symptoms, impacts on daily life, and healthcare needs.See study design
What are the potential side effects?
While specific side effects are not detailed here as it depends on individual cases and the nature of interventions being non-pharmaceutical; generally there may be discomfort or mild pain associated with manual drainage techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I have been diagnosed with head and neck lymphedema and referred by a cancer specialist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after end of intervention (an average of 6 weeks), 6-month post-intervention, 12-month post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after end of intervention (an average of 6 weeks), 6-month post-intervention, 12-month post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in severity of lymphedema
Secondary outcome measures
Changes in degrees of cervical range of motion
Changes in degrees of jaw range of motion
Changes in severity of symptom burden
Other outcome measures
Healthcare utilization

Trial Design

2Treatment groups
Active Control
Group I: Clinic-Based Lymphedema TherapyActive Control1 Intervention
Group II: Home-Based (a hybrid model) Lymphedema TherapyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,395 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
550 Previous Clinical Trials
29,996,648 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,788 Total Patients Enrolled

Media Library

Clinic-Based Lymphedema Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05182229 — N/A
Clinic-Based Lymphedema Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05182229 — N/A
Head and Neck Cancers Research Study Groups: Clinic-Based Lymphedema Therapy, Home-Based (a hybrid model) Lymphedema Therapy
Head and Neck Cancers Clinical Trial 2023: Clinic-Based Lymphedema Therapy Highlights & Side Effects. Trial Name: NCT05182229 — N/A
Head and Neck Cancers Patient Testimony for trial: Trial Name: NCT05182229 — N/A

Frequently Asked Questions

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

Are there any patients that have yet to be enrolled in this research project?

"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov from August 22nd, 2022. The trial was initially posted on March 11th, 2020."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Delaware
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Pennsylvania
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m need relief from the swelling and pain. I had Melanoma on my foot ...it was removed in 2003 at U of P by Dr Chang....I can't live with this leg lymphedema ....Please help me!!
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. University of Pennsylvania: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Comparing Two Ways to Manage Head and Neck Lymphedema
Jie Deng 2022. "Comparing Two Ways to Manage Head and Neck Lymphedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05182229.
All > Lymphedema New York > Lymphedema
~58 spots leftby Oct 2024
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