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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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe swelling due to lymphedema.
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I have had carotid artery disease.
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I have no conditions that would make lymphedema therapy unsafe.
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I have an ongoing infection in the soft tissues of my head or neck.

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

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

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
~0 spots leftby Oct 2024