A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation

Head and Neck Carcinoma Clinical Trial

Official title:

Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05512767
• Other study ID #: 21-003342
• Secondary ID: NCI-2022-06767
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 22, 2024

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 22, 2024
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Carcinoma
• Head and Neck Neoplasms
• Laryngeal Neoplasms
• Lip Neoplasms
• Mouth Neoplasms
• Oropharyngeal Neoplasms
• 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

Intervention

Other:
• Best Practice
Undergo self-manual lymphatic drainage
• Consensus Auditory-Perceptual Evaluation of Voice
Ancillary studies

Procedure:
• Diagnostic Imaging
Undergo photographs of face and neck

Other:
• Lymphedema Management
Undergo skilled lymphedema treatment by a therapist

Procedure:
• Modified Barium Swallow
Undergo swallow study
• Nasopharyngeal Laryngoscopy
Undergo Nasolaryngoscopy

Device:
• Pneumatic Compression Therapy
Undergo compression therapy - Flexitouch Plus System is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides systematic and sequential pressure changes to move fluid to intact lymphatic chains.

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Voice Handicap Index-10
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare composite measurements of the face and neck for lymphatic drainage	Will be completed at baseline and at the conclusion of the study to assess and compare the effects of traditional manual lymphatic drainage to those from use of a pneumatic compression system.	Change from baseline and up to 12 weeks
Primary	Change in lymphedema of the head and neck	A reduction in one grade on the Mayo Clinic Lymphedema - head and neck (HN) Grading Scale (MCLGS) or one stage on the MD Anderson Cancer Center (MDACC) grading system for lymphedema of the head and neck.	Up to 12 weeks
Secondary	Improvements on quality of life (QOL) function	Measured by QOL questionnaire and Facial and Neck Composite Measurements; Status Scale: PSS-HN	Up to 12 weeks
Secondary	Improvements on voice function	Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V	Up to 12 weeks
Secondary	Improvements on swallowing function	Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance	Up to 12 weeks