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Comparing Two Ways to Manage Head and Neck Lymphedema

Abramson Cancer Center at Penn Medicine logo

Abramson Cancer Center at Penn Medicine

Status

Enrolling

Conditions

Lymphedema
Head and Neck Cancer

Treatments

Other: Home-based (a hybrid model) CDT
Other: Clinic-based CDT

Study type

Interventional

Funder types

Other

Identifiers

NCT05182229
UPCC 20321

Details and patient eligibility

About

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.

Full 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

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Clinic-Based Lymphedema Therapy
Active Comparator group
Treatment:
Other: Clinic-based CDT
Home-Based (a hybrid model) Lymphedema Therapy
Active Comparator group
Treatment:
Other: Home-based (a hybrid model) CDT

Trial contacts and locations

6

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Central trial contact

Jie Deng, PhD

Data sourced from clinicaltrials.gov

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