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Clinic-Based versus Home-Based Therapy for the Management of Lymphedema in Head and Neck Cancer Survivors
Trial Status: active
This clinical trial compares the effect of clinic-based (therapy completed at a physical therapy clinic) to home-based (a hybrid model both in the clinic and self-care at home) in managing lymphedema that has developed after cancer treatments in head and neck cancer survivors. Lymphedema is the build-up of fluid in soft body tissues when the lymph system is damaged or blocked. A home-based, hybrid model may help reduce the severity of lymphedema in head and neck cancer survivors.
Inclusion Criteria
> 18 years of age
3-12 months post-head and neck cancer (HNC) treatment
No evidence of cancer
Diagnosis of head and neck lymphedema and referral by their oncologists or care team
Not in active lymphedema therapy or physical therapy
Able to provide informed consent
Able to perform self-manual lymphatic drainage (self-manual lymphatic drainage [MLD])
Having an electronic device (a computer, tablet, iPad, laptop or smartphone) and internet access at home
Exclusion Criteria
Active cancer
Acute infection
Acute congestive heart failure
Acute renal failure
Acute cardiac or pulmonary edema
Sensitive carotid sinus
Severe carotid blockage
Uncontrolled hypertension
Jugular vein thrombosis
Significantly severe lymphedema (e.g., severe periorbital swelling)
Additional locations may be listed on ClinicalTrials.gov for NCT05182229.
I. To compare the effects of clinic-based and home-based complete decongestive therapy (CDT) on changes in the severity of lymphedema.
SECONDARY OBJECTIVE:
I. To compare the effects of clinic-based and home-based CDT on symptom burden and functional status.
EXPLORATORY OBJECTIVE:
I. To compare the healthcare utilization between patients receiving clinic-based versus home-based CDT.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1 (CLINIC-BASED): Patients receive therapist-administered, in-person complete decongestive therapy (CDT) twice weekly for 6 weeks.
ARM 2 (HOME-BASED): Patients receive therapist-administered, in-person CDT twice weekly for 2 weeks, followed by real-time video CDT consultations twice weekly for 3 weeks.
After completion of study treatment, patients are followed up at 6 months and 12 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
