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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

No Placebo-Only Group

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 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

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.