Head and Neck CancerNCT05182229
Comparing Two Ways to Manage Head and Neck Lymphedema
A study testing Home-based (a hybrid model) CDT and Clinic-based CDT in people with Head and Neck Cancer and Lymphedema, run by Abramson Cancer Center at Penn Medicine at 6 sites in United States.
Trial summary
This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lymphedema
- What is being tested?
- Home-based (a hybrid model) CDT and Clinic-based CDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Mar 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Jefferson Cherry Hospital Jefferson Health
Cherry Hill, New Jersey, 08002
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jefferson Health
Philadelphia, Pennsylvania, 19107
Jefferson Torresdale Hospital Jefferson Health
Philadelphia, Pennsylvania, 19114
Temple University Hospital and Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19140
Asplundh Cancer Pavilion Jefferson Health
Willow Grove, Pennsylvania, 19090
About this study
Official title: Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors
This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.
Read the detailed description
Primary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on changes in the severity of lymphedema.
Secondary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on symptom burden and functional status.
Exploratory aim: To compare the healthcare utilization between patients receiving clinic-based versus home-based (a hybrid model) CDT
- Conditions
- Head and Neck Cancer, Lymphedema
- Being tested
- Home-based (a hybrid model) CDT, Clinic-based CDT
- Medical subject headings
- Head and Neck Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based (a hybrid model) CDTOther
Participants will be provided therapist-administered, in person complete decongestive therapy (CDT) two times per week for two weeks (4 sessions), followed by real-time, virtual CDT consultations two times per week for three weeks (7 sessions) and one in person follow-up visit.
Clinic-based CDTOther
Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Clinic-Based Lymphedema Therapy | Active comparator | Not described Receives: Other: Clinic-based CDT |
| Home-Based (a hybrid model) Lymphedema Therapy | Active comparator | Not described Receives: Other: Home-based (a hybrid model) CDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in severity of lymphedema
Compare the effects of clinic-based and home-based CDT on changes in the severity of lymphedema. This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria).
Measured: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Secondary outcomes (3)
Changes in severity of symptom burden
Compare the effects of clinic-based and home-based CDT on changes in the severity of symptom burden. This outcome measure will be assessed via Head and Neck - Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory)
Measured: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Changes in degrees of jaw range of motion
Compare the effects of clinic-based and home-based CDT on jaw range of motion. Jaw range of motion will be measured via Jaw Range of Motion Scale.
Measured: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Changes in degrees of cervical range of motion
Compare the effects of clinic-based and home-based CDT on cervical range of motion. Cervical Range of Motion will be measured via Cervical Range of Motion Instrument.
Measured: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start11 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jie Deng, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182229
- Sponsor's protocol ID
- UPCC 20321
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors
- ClinicalTrials.gov ID
- NCT05182229
- Acronym / sponsor ID
- UPCC 20321
- Conditions
- Head and Neck Cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.
Detailed description
Primary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on changes in the severity of lymphedema.
Secondary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on symptom burden and functional status.
Exploratory aim: To compare the healthcare utilization between patients receiving clinic-based versus home-based (a hybrid model) CDT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic-Based Lymphedema Therapy | Active comparator | Other: Clinic-based CDT |
| Home-Based (a hybrid model) Lymphedema Therapy | Active comparator | Other: Home-based (a hybrid model) CDT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based (a hybrid model) CDTParticipants will be provided therapist-administered, in person complete decongestive therapy (CDT) two times per week for two weeks (4 sessions), followed by real-time, virtual CDT consultations two times per week for three weeks (7 sessions) and one in person follow-up visit. | Other | Home-Based (a hybrid model) Lymphedema Therapy |
| Clinic-based CDTParticipants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions). | Other | Clinic-Based Lymphedema Therapy |
Primary outcome
Changes in severity of lymphedema
Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Compare the effects of clinic-based and home-based CDT on changes in the severity of lymphedema. This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria).
3 secondary outcomes
Changes in severity of symptom burden
Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Changes in degrees of jaw range of motion
Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Changes in degrees of cervical range of motion
Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based (a hybrid model) CDT and Clinic-based CDT in people with Head and Neck Cancer and Lymphedema, run by Abramson Cancer Center at Penn Medicine at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in severity of lymphedema (time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.