NCT06125743 · Abramson Cancer Center at Penn Medicine
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
What this study is about
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.
View original scientific description
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \>18 years of age
- Post HNC primary treatment
- No evidence of cancer (NED)
- Completion of initial lymphedema therapy for head and neck lymphedema
- Unable to obtain lymphedema therapy due to barriers noted above
- History of lymphedema on the face and neck, with or without fibrosis
- Ability to understand English in order to complete questionnaires
- Ability to perform self-care activities for LEF management
- Ability to provide informed consent
- Having an electronic device (a computer, tablet, iPad, or smartphone) and internet access at home
- A valid email address
Exclusion criteria
- Recurrent or metastatic cancer
- Any other active cancer
- Acute infection
- Acute congestive heart failure
- Acute renal failure
- Cardiac or pulmonary edema
- Sensitive carotid sinus
- Severe carotid blockage
- Uncontrolled hypertension
- Venous thrombosis
- Pregnant people
- Incarcerated patients
Where
- Philadelphia, Pennsylvania
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2025 · Source of record for eligibility and locations