Comparing Two Ways to Manage Head and Neck Lymphedema

NCT ID: NCT05182229

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2026-11-30

Brief Summary

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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

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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

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Head and Neck Cancer Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clinic-Based Lymphedema Therapy

Group Type ACTIVE_COMPARATOR

Clinic-based CDT

Intervention Type OTHER

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

Home-Based (a hybrid model) Lymphedema Therapy

Group Type ACTIVE_COMPARATOR

Home-based (a hybrid model) CDT

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Clinic-based CDT

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jie Deng

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jefferson Cherry Hospital Jefferson Health

Cherry Hill, New Jersey, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Jefferson Health

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Jefferson Torresdale Hospital Jefferson Health

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Temple University Hospital and Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Asplundh Cancer Pavilion Jefferson Health

Willow Grove, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jie Deng, PhD

Role: CONTACT

215-573-2393

Facility Contacts

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Bryan Spinelli, PT, PhD

Role: primary

215-503-5011

Jie Deng, PhD, RN, OCN, FAAN

Role: primary

215-573-2393

Bryan A Spinelli, PT, PhD

Role: primary

215-503-5011

Bryan Spinelli, PT, PhD

Role: primary

215-503-5011

Akina Tamaki, MD

Role: primary

215-707-3665

Bryan Spinelli, PT, PhD

Role: primary

215-503-5011

Other Identifiers

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UPCC 20321

Identifier Type: -

Identifier Source: org_study_id

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