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

NCT05512767 | Withdrawn FDA Device

• 2 other identifiers: 21-003342NCI-2022-06767
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Improvements on quality of life (QOL) function

  Up to 12 weeks

• Improvements on voice function

  Up to 12 weeks

• Improvements on swallowing function

  Up to 12 weeks

Study Arms (2)

Group I (pneumatic therapy, lymphedema management)

EXPERIMENTAL

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.

Other: Consensus Auditory-Perceptual Evaluation of Voice; Procedure: Diagnostic Imaging; Other: Lymphedema Management; Procedure: Modified Barium Swallow; Procedure: Nasopharyngeal Laryngoscopy; Device: Pneumatic Compression Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Voice Handicap Index-10

Group II (standard of care, lymphedema management)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Consensus Auditory-Perceptual Evaluation of Voice; Procedure: Diagnostic Imaging; Other: Lymphedema Management; Procedure: Modified Barium Swallow; Procedure: Nasopharyngeal Laryngoscopy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Voice Handicap Index-10

Interventions

Best Practice OTHER

Undergo self-manual lymphatic drainage

Also known as: standard of care, standard therapy

Group II (standard of care, lymphedema management)

Consensus Auditory-Perceptual Evaluation of Voice OTHER

Ancillary studies

Also known as: CAPE-V, Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

Group I (pneumatic therapy, lymphedema management); Group II (standard of care, lymphedema management)

Diagnostic Imaging PROCEDURE

Undergo photographs of face and neck

Also known as: Medical Imaging

Group I (pneumatic therapy, lymphedema management); Group II (standard of care, lymphedema management)

Lymphedema Management OTHER

Undergo skilled lymphedema treatment by a therapist

Group I (pneumatic therapy, lymphedema management); Group II (standard of care, lymphedema management)

Modified Barium Swallow PROCEDURE

Undergo swallow study

Also known as: MBS, VFSS, Videofluoroscopic Swallowing Study

Group I (pneumatic therapy, lymphedema management); Group II (standard of care, lymphedema management)

Nasopharyngeal Laryngoscopy PROCEDURE

Undergo Nasolaryngoscopy

Group I (pneumatic therapy, lymphedema management); Group II (standard of care, lymphedema management)

Pneumatic Compression Therapy DEVICE

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.

Also known as: Flexi-touch Plus System

Group I (pneumatic therapy, lymphedema management)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (pneumatic therapy, lymphedema management); Group II (standard of care, lymphedema management)

Questionnaire Administration OTHER

Ancillary studies

Group I (pneumatic therapy, lymphedema management); Group II (standard of care, lymphedema management)

Voice Handicap Index-10 OTHER

Ancillary studies

Also known as: VHI-10, Voice Handicap Index-10 (VHI-10)

Group I (pneumatic therapy, lymphedema management); Group II (standard of care, lymphedema management)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Carcinoma

Interventions

Practice Guidelines as Topic; Standard of Care; X-Rays; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Mouth Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Drug Therapy; Therapeutics

Study Officials

• Lisa Crujido

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 23, 2022
• Study Start: December 1, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2024
• Last Updated: January 6, 2023

Record last verified: 2023-01