NCT05182229

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable head-and-neck-cancer

Timeline
13mo left

Started Mar 2022

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2022Jun 2027

First Submitted

Initial submission to the registry

December 12, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

December 12, 2021

Last Update Submit

April 30, 2026

Conditions

Head and Neck CancerLymphedema

Outcome Measures

Primary Outcomes (1)

  • Changes in severity of lymphedema

    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).

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

Secondary Outcomes (3)

  • Changes in severity of symptom burden

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

  • Changes in degrees of jaw range of motion

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

  • Changes in degrees of cervical range of motion

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

Other Outcomes (2)

  • Healthcare utilization

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

  • Healthcare utilization

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

Study Arms (2)

Clinic-Based Lymphedema Therapy

ACTIVE COMPARATOR
Other: Clinic-based CDT

Home-Based (a hybrid model) Lymphedema Therapy

ACTIVE COMPARATOR
Other: Home-based (a hybrid model) CDT

Interventions

Home-based (a hybrid model) CDTOTHER

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.

Home-Based (a hybrid model) Lymphedema Therapy
Clinic-based CDTOTHER

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

Clinic-Based Lymphedema Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Jefferson Cherry Hospital Jefferson Health

Cherry Hill, New Jersey, 08002, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Torresdale Hospital Jefferson Health

Philadelphia, Pennsylvania, 19114, United States

Location

Temple University Hospital and Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19140, United States

Location

Asplundh Cancer Pavilion Jefferson Health

Willow Grove, Pennsylvania, 19090, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLymphedema

Interventions

carbohydrate-deficient transferrin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2021

First Posted

January 10, 2022

Study Start

March 11, 2022

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

US(6)