A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of He… (NCT04797390) | Clinical Trial Compass
CompletedNot Applicable
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
United States236 participantsStarted 2021-09-23
Plain-language summary
To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary)
. Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment
. A diagnosis of either internal or external head and neck lymphedema
. At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening
. Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation
. Must be able to speak and understand English
Exclusion criteria
. Previous APCD or Usual Care treatment for HNC LEF
. Acute facial infection (e.g., facial or parotid gland abscess)
. Known carotid sinus hypersensitivity syndrome
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Internal Lymphedema - Endoscopy
Timeframe: Change from Baseline at 2 months, 4 months, 6 months
2
Internal Lymphedema - CT Imaging
Timeframe: Change from Baseline at 2 months, 6 months
3
Internal Lymphedema - CT Imaging
Timeframe: Change from Baseline at 2 months, 6 months
4
External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading
Timeframe: Change from Baseline at 2 months, 4 months, 6 months
5
External Lymphedema - Digital Photography
Timeframe: Change from Baseline at 2 months, 4 months, 6 months
6
Symptom Burden - Lymphedema Symptom Intensity and Distress Survey
Timeframe: Change from Baseline at 2 months, 4 months, 6 months
7
Physical Function - Vanderbilt Head and Neck Symptom Survey
Timeframe: Change from Baseline at 2 months, 4 months, 6 months