Clinical trial · Interventional
Comparing Two Ways to Manage Head and Neck Lymphedema
Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors
NCT05182229CI-TRIAL-00110561active not recruitingN/AClinicalTrials.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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinic-based CDT | Other | — | UNRESOLVED |
| Home-based (a hybrid model) CDT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Clinic-Based Lymphedema Therapy
- interventionNames
- Other: Clinic-based CDT
- type
- ACTIVE_COMPARATOR
- label
- Home-Based (a hybrid model) Lymphedema Therapy
- interventionNames
- Other: Home-based (a hybrid model) CDT
Primary outcomes (1)
- measure
- Changes in severity of lymphedema
- timeFrame
- Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.