Clinical trial NCT05512767: A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation
Official title: Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma
Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma
Clinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal Carcinoma
Head and Neck Carcinoma
Stage II Hypopharyngeal Carcinoma AJCC v8
Stage II Laryngeal Cancer AJCC v8
Stage II Lip and Oral Cavity Cancer AJCC v8
Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage III Hypopharyngeal Carcinoma AJCC v8
Stage III Laryngeal Cancer AJCC v8
Stage III Lip and Oral Cavity Cancer AJCC v8
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IV Hypopharyngeal Carcinoma AJCC v8
Stage IV Laryngeal Cancer AJCC v8
Stage IV Lip and Oral Cavity Cancer AJCC v8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Lymphedema can be the result of surgery, radiation therapy, chemotherapy or any combination of these procedures. Internal lymphedema has been shown to negatively affect speech production, swallowing, respiration, and voice. Flexitouch is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides pressure changes to move lymph fluid from the impaired area toward healthy regions of the body. Complete decongestive therapy (CDT) is standard of care for treating external lymphedema and involves manual lymphatic drainage (MLD) performed by licensed therapists followed by compression therapy. CDT has long been used for treating lymphedema of the limbs. Combining a pneumatic compression system with standard of care manual lymphatic drainage may have positive effects on speech, voice, and swallowing.

Detailed description: PRIMARY OBJECTIVES:

I. Compare success rates in reducing internal and external lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). Assess efficacy of PCD and MLD.

II. Assess compliance of treatment in both groups. III. Assess changes in voice and swallowing in both groups.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.

GROUP II: Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.

Eligibility criteria: Inclusion Criteria:

* Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent
* Cognitive function adequate to understand and execute the elements of the protocol
* Willingness and ability to return to Mayo Clinic for follow-up care per protocol
* Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)
* Must demonstrate oropharyngeal competency that would allow some oral intake

Exclusion Criteria:

* Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer
* Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative
* Acute facial infection
* Active congestive heart failure (CHF) or pulmonary edema
* Symptomatic carotid artery disease or bradycardia
* Increased intracranial pressure
* History of multiple cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs)
* \> 50% internal carotid artery (ICA) blockage
* Upper quadrant deep vein thrombosis
* Known esophageal obstruction
* Percutaneous endoscopic gastrostomy (PEG) tube dependence with no oral intake
* Women of child-bearing potential
* (Active) pregnancy

Primary outcomes:
measure: Compare composite measurements of the face and neck for lymphatic drainage
timeFrame: Change from baseline and up to 12 weeks
measure: Change in lymphedema of the head and neck
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Improvements on quality of life (QOL) function
timeFrame: Up to 12 weeks
measure: Improvements on voice function
timeFrame: Up to 12 weeks
measure: Improvements on swallowing function
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Lisa Crujido
role: PRINCIPAL_INVESTIGATOR
References: