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Active, Not Recruiting

NCT Number: NCT05182229

Comparing Two Ways to Manage Head and Neck Lymphedema

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jefferson Cherry Hospital Jefferson Health, Cherry Hill, New Jersey, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based (a hybrid model) CDT

Other

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 CDT

Other

Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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)

  2. 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

    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.

  3. 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

    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.

Other outcomes

  1. Healthcare utilization

    Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention

    Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Healthcare Utilization Questionnaire will be used in this study.

  2. Healthcare utilization

    Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention

    Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Electronic Health Records (EHR) will be used in this study.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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