CDT Management for Head and Neck Cancer-Related Lymphedema
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Abramson Cancer Center at Penn Medicine
Disqualifiers: Active infection, Carotid artery occlusion, Severe lymphedema, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment CDT Management for Head and Neck Cancer-Related Lymphedema?
Research shows that complex decongestive therapy (CDT) is effective in reducing swelling in patients with lymphedema, particularly after breast cancer surgery. Studies have found that both professionally administered and self-administered CDT can improve lymphedema and enhance quality of life.
12345Is complex decongestive therapy (CDT) safe for humans?
Complex decongestive therapy (CDT) is considered non-invasive, painless, and without side effects, making it generally safe for humans.
12346How is CDT different from other treatments for head and neck cancer-related lymphedema?
Complex decongestive therapy (CDT) is unique because it is a non-invasive, painless treatment that combines multiple physical therapy techniques to reduce swelling, and it is already considered the standard treatment for lymphedema in other conditions like breast cancer. Unlike some treatments that may involve medication or surgery, CDT focuses on physical methods to manage lymphedema without side effects.
12347Eligibility Criteria
This trial is for adults over 18 who have head and neck lymphedema within 24 months after cancer treatment. They must be referred by their oncology providers, able to do self-manual lymph drainage, and have internet access plus a digital device at home. It's not for those with active infections in the area, carotid artery disease, or very severe lymphedema.Inclusion Criteria
I am 18 years old or older.
It has been 2 years or less since my head and neck cancer treatment.
I can perform lymphatic drainage on myself.
+2 more
Exclusion Criteria
I have severe swelling due to lymphedema.
I have had carotid artery disease.
I have no conditions that would make lymphedema therapy unsafe.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive clinic-based or home-based CDT for lymphedema management
6 weeks
Follow-up
Participants are monitored for changes in lymphedema severity, symptom burden, and functional status
12 months
Participant Groups
The study compares two treatments for managing lymphedema: one where patients go to a clinic (Clinic-based CDT) and another they can do at home using a hybrid model (Home-based CDT). The goal is to see which method better reduces swelling severity, symptoms, impacts on daily life, and healthcare needs.
2Treatment groups
Active Control
Group I: Clinic-Based Lymphedema TherapyActive Control1 Intervention
Group II: Home-Based (a hybrid model) Lymphedema TherapyActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
Thomas Jefferson UniversityPhiladelphia, PA
Temple University Hospital and Fox Chase Cancer CenterPhiladelphia, PA
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Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
University of PennsylvaniaLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
Pilot Study: The Effectiveness of Complex Decongestive Therapy for Lymphedema in Palliative Care Patients with Advanced Cancer. [2019]Complex decongestive therapy (CDT) is a regimen of physical treatment for lymphedema. Its effectiveness is unknown in advanced cancer patients. This study evaluates effectiveness of CDT in this population.
Long-term effects of complex decongestive therapy in breast cancer patients with arm lymphedema after axillary dissection. [2021]To investigate the long-term effects of complex decongestive therapy (CDT) on edema reduction in breast cancer-related lymphedema patients after axillary dissection, according to the initial volume of edema.
Effectiveness of six-step complex decongestive therapy for treating upper limb lymphedema after breast cancer surgery. [2022]Complex decongestive therapy (CDT) is currently recommended as the standard treatment for lymphedema. CDT is a four-step detumescence therapy that can effectively treat upper limb lymphedema after breast cancer surgery, and is considered non-invasive, painless and without side effects.
Efficacy of self-administered complex decongestive therapy on breast cancer-related lymphedema: a single-blind randomized controlled trial. [2019]After surgery, breast cancer-related lymphedema (BCRL) is a frequent chronic condition. The complex decongestive therapy (CDT) delivered by physiotherapists at hospitals is the state-of-the-art treatment choice. As lymphedema requires continuous management, we designed a 1-month-long course to train women to professionally carry out a self-administered CDT (saCDT) and tested its efficacy while keeping the benefits of CDT.
Self-administration of complex decongestive therapy facilitated by the mobile application WeChat improves lymphedema and quality of life in breast cancer survivors: an observational study. [2022]Lymphedema is the most common complication of breast cancer patients. Complex decongestive therapy (CDT) is often recommended but the efficacy varies due to the complexity of management. This study investigated a novel model of CDT based on a mobile application with the aim of improving the management of lymphedema in China.
Application of complete decongestive therapy after lymphaticovenular anastomosis of the lower limb combined with liposuction-A retrospective study research. [2023]Complete decongestive therapy (CDT) is a conservative treatment for lymphedema that combines interventions and lifestyle changes. We evaluated the application of CDT after lymphaticovenular anastomosis (LVA) of the lower limb combined with liposuction.
Prospective trial of complete decongestive therapy for upper extremity lymphedema after breast cancer therapy. [2019]Lymphedema is a well-described complication of therapy for breast cancer. Patients who present with lymphedema may experience pain and body image issues and are at increased risk for developing cellulitis. Complete decongestive therapy (CDT) is a four-component therapy for lymphedema. Data regarding CDT as an intervention in the immediate after the diagnosis period and prolonged follow-up are limited; we prospectively analyzed results of CDT in this cohort of patients.