Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Self-management program for lymphedema in head and neck cancer survivors

Official title: Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]

Run by Abramson Cancer Center at Penn Medicine · NCT06125743 · Data updated 2026-11-12

This study is testing a self-management program for lymphedema in head and neck cancer survivors to see if in-person or telehealth support helps them feel better compared to usual care.

More Lymphedema of the Head and Neck trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment204 (estimated)
SponsorAbramson Cancer Center at Penn Medicine
Academic / other
Locations2 sites (Philadelphia, Pennsylvania and 1 other locations)
StatusRecruiting
StartedMarch 29, 2024
Main results expectedAugust 31, 2027
Study endsAugust 31, 2027
Registry record updatedNovember 10, 2026
Trial IDNCT06125743 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old who have completed primary treatment for head and neck cancer and have a history of lymphedema in the face and neck.

Probably not a fit

Patients with recurrent or metastatic cancer, other active cancers, or severe acute health conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a standardized self-management program for lymphedema and fibrosis (LEF-SMP) in head and neck cancer survivors. Participants will be assigned to one of three groups: in-person LEF-SMP, telehealth LEF-SMP, or usual care. The study aims to compare the impact of these interventions on lymphedema severity, symptom burden, functional impairments, and overall quality of life. Additionally, it will assess improvements in patients' knowledge, skills, self-efficacy, and adherence to self-care practices.

Why it matters

Potential benefit: If successful, this program could significantly improve the quality of life and self-management capabilities of patients suffering from lymphedema and fibrosis after head and neck cancer treatment.

How similar studies have gone: Other studies have shown promise in self-management approaches for lymphedema, suggesting potential success for this program.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 it's running

  • University of Pennsylvania
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Photobiomodulation for chronic head and neck lymphedema

    This will test whether photobiomodulation (low-level laser) can reduce chronic lymphedema in people who were treated for head and neck cancer.

    Recruiting at 2 sites Abramson Cancer Center at Penn Medicine · Philadelphia, Pennsylvania and 1 other locations · NCT06837480

  • Head and neck lymphedema treatment using the Symani robotic system

    This study tests whether the Symani Surgical System can safely and effectively help connect small blood and lymph vessels during head and neck lymphatic reconstruction.

    Recruiting MMI (Medical Microinstruments, Inc.) · Kiel · NCT07311876

  • Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)

    This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.

    Recruiting Phase 2 Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07919444

  • Airway ultrasound in head and neck cancer patients

    This observational study tests whether neck ultrasound measurements of the airway match CT measurements in adults with maxillofacial cancer undergoing surgery with anesthesia.

    Recruiting at 2 sites University Hospital Dubrava · Zagreb, City of Zagreb and 1 other locations · NCT07910149

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    Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07882888

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.