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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
Must not have
Significantly severe lymphedema (e.g., severe periorbital swelling)
History of carotid artery disease
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
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.
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.
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 belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with head and neck lymphedema and referred by a cancer specialist.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe swelling due to lymphedema.
Select...
I have had carotid artery disease.
Select...
I have no conditions that would make lymphedema therapy unsafe.
Select...
I have an ongoing infection in the soft tissues of my head or neck.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately after end of intervention (an average of 6 weeks), 6-month post-intervention, 12-month post-intervention
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in severity of lymphedema
Secondary study objectives
Changes in degrees of cervical range of motion
Changes in degrees of jaw range of motion
Changes in severity of symptom burden
Other study objectives
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
411 Previous Clinical Trials
158,637 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
572 Previous Clinical Trials
27,077,274 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,063 Previous Clinical Trials
42,711,612 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe swelling due to lymphedema.I have had carotid artery disease.I am 18 years old or older.I have no conditions that would make lymphedema therapy unsafe.I have been diagnosed with head and neck lymphedema and referred by my cancer doctor.It has been 2 years or less since my head and neck cancer treatment.I can perform lymphatic drainage on myself.I finished my head or neck cancer treatment within the last 2 years.I have an ongoing infection in the soft tissues of my head or neck.I am older than 18 years.I have been diagnosed with head and neck lymphedema and referred by a cancer specialist.You have an electronic device and internet access at home.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Clinic-Based Lymphedema Therapy
- Group 2: Home-Based (a hybrid model) Lymphedema Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Head and Neck Cancers Patient Testimony for trial: Trial Name: NCT05182229 — N/A
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