Comparing clinic-based and home-based treatments for head and neck lymphedema
Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors
NA · Abramson Cancer Center at Penn Medicine · NCT05182229
This study is testing whether getting lymphedema treatment at home works as well as going to a clinic for people who have survived head and neck cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine (other) |
| Locations | 6 sites (Cherry Hill, New Jersey and 5 other locations) |
| Trial ID | NCT05182229 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of clinic-based complete decongestive therapy (CDT) versus a hybrid model of home-based CDT for managing lymphedema in survivors of head and neck cancer. The primary focus is on assessing changes in the severity of lymphedema, while secondary outcomes include symptom burden and functional status. Additionally, the study will explore differences in healthcare utilization between the two treatment approaches. Participants will be randomly assigned to either treatment group to evaluate the outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are within 24 months post-treatment for head and neck cancer and have been diagnosed with head and neck lymphedema.
Not a fit: Patients with active infections in the head and neck region or those with severe lymphedema may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with more effective management options for lymphedema, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promising results with similar approaches to managing lymphedema, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years of age * \<=24 months post-HNC treatment * Diagnosis of head and neck lymphedema and referral by their oncology providers * Able to perform self-manual lymphatic drainage * Having an electronic device (a computer, tablet, iPad, laptop, or smartphone) and internet access at home Exclusion Criteria: * Active infection in soft tissues in the head and neck region * History of moderate or severe carotid artery occlusion * Significantly severe lymphedema (e.g., severe periorbital swelling) * Conditions impacting the safe delivery of lymphedema therapy
Where this trial is running
Cherry Hill, New Jersey and 5 other locations
- Jefferson Cherry Hospital Jefferson Health — Cherry Hill, New Jersey, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Jefferson Health — Philadelphia, Pennsylvania, United States (RECRUITING)
- Jefferson Torresdale Hospital Jefferson Health — Philadelphia, Pennsylvania, United States (NOT_YET_RECRUITING)
- Temple University Hospital and Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
- Asplundh Cancer Pavilion Jefferson Health — Willow Grove, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Jie Deng, PhD
- Email: jiedeng@nursing.upenn.edu
- Phone: 215-573-2393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer, Lymphedema