Clinical trial · Interventional
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema
NCT04797390CI-TRIAL-00104337completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema Due to Radiation | — | UNRESOLVED | — |
| Lymphedema of Face | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
| Lymphedema; Surgical | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Advanced Pneumatic Compression Device (APCD) | Device | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Advanced Pneumatic Compression Device (APCD)
- description
- Daily self-administered treatment with the Flexitouch® Plus system (FT)
- interventionNames
- Device: Advanced Pneumatic Compression Device (APCD)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist
- interventionNames
- Other: Usual Care
Primary outcomes (13)
- measure
- Internal Lymphedema - Endoscopy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary) 3. Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment 4. A diagnosis of either internal or external head and neck lymphedema 5. At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening 6. Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation 7. Must be able to speak and understand English Exclusion Criteria: 1. Previous APCD or Usual Care treatment for HNC LEF 2. Acute facial infection (e.g., facial or parotid gland abscess) 3. Known carotid sinus hypersensitivity syndrome 4. Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness) 5. Internal jugular venous thrombosis (within 3 months) 6. Patient is pregnant or trying to become pregnant
References
Publications (2)
- DERIVEDRidner SH, Smith DK, Kline-Quiroz CM, Jensen KM, Sukari AW, Bhayani MK, Mehta V, Shah JL, Willey CD, Dunlap NE, Lee HK, Aulino JM, Murphy BA. Long-Term Outcomes of Advanced Pneumatic Compression Device vs. Usual Care Therapy for Head and Neck Cancer-Related Lymphedema: A Multi-Site Randomized Clinical Trial. Int J Radiat Oncol Biol Phys. 2026 Aug 3:S0360-3016(26)04071-X. doi: 10.1016/j.ijrobp.2026.07.030. Online ahead of print. PMID 42546804
- DERIVEDMurphy BA, Smith DK, Kline-Quiroz CM, Jensen KM, Sukari AW, Bhayani MK, Mehta V, Quon H, Shah JL, Willey CD, Dunlap NE, Lee HK, Aulino JM, Ridner SH. Short-Term Outcomes of Advanced Pneumatic Compression Device Versus Usual Care Therapy for Head and Neck Cancer-Related Lymphedema: A Multi-Site Randomized Clinical Trial. Head Neck. 2026 Apr;48(4):1077-1087. doi: 10.1002/hed.70155. Epub 2026 Jan 23. PMID 41574713