NCT05182229

Comparing Two Ways to Manage Head and Neck Lymphedema

Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Home-based (a hybrid model) CDT	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.
OTHER	Clinic-based CDT	Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).

Timeline

• Start date: 2022-03-11
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2022-01-10
• Last updated: 2025-04-30

Locations

6 sites across 1 country: United States