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A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema

Cancer Categories

Head and Neck

Karmanos Trial ID

2022-047

NCT ID

NCT04797390

Age Group

Adult

Scope

National

Phase

N/A

Principal Investigator

Ammar
Sukari, M.D.
Oncology - Medical View Profile

Objective:

Primary Objective:

Our long-term goal is to improve outcomes for individuals suffering from LEF. The overall objective for this study is to conduct a randomized clinical trial comparing the effectiveness of APCD and Usual Care for the management of LEF

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Eligibility

Eligibility

Inclusion Criteria:

Age ≥ 18 years
Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary)
Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment
A diagnosis of either internal or external head and neck lymphedema
At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening
Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation
Must be able to speak and understand English

Exclusion Criteria:

Previous APCD or Usual Care treatment for HNC LEF
Acute facial infection (e.g., facial or parotid gland abscess)
Known carotid sinus hypersensitivity syndrome
Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
Internal jugular venous thrombosis (within 3 months)
Patient is pregnant or trying to become pregnant

Locations

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices