Neoplasms

All Conditions

Blood and Lymph Conditions

Mouth and Tooth Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Head and Neck Neoplasms

Lymphedema

Mouth Neoplasms

Laryngeal Neoplasms

Oropharyngeal Neoplasms

Lip Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Otorhinolaryngologic Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Pharyngeal Diseases

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

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.

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.

Best Practice

Consensus Auditory-Perceptual Evaluation of Voice

Diagnostic Imaging

Undergo skilled lymphedema treatment by a therapist

Lymphedema Management

Modified Barium Swallow

Nasopharyngeal Laryngoscopy

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.

Pneumatic Compression Therapy

Quality-of-Life Assessment

Questionnaire Administration

Voice Handicap Index-10

Lisa Crujido

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.

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.

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

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

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.

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.

Measured by QOL questionnaire and Facial and Neck Composite Measurements

Status Scale:

PSS-HN

Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V

Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance

Mayo Clinic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation	NCT05512767	Clinical Stage ... Clinical Stage ... Clinical Stage ... Head and Neck C... Stage II Hypoph... Stage II Laryng... Stage II Lip an... Stage II Oropha... Stage III Hypop... Stage III Laryn... Stage III Lip a... Stage III Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Lip an... Stage IV Oropha...	Best Practice Consensus Audit... Diagnostic Imag... Lymphedema Mana... Modified Barium... Nasopharyngeal ... Pneumatic Compr... Quality-of-Life... Questionnaire A... Voice Handicap ...	18 Years -	Mayo Clinic
A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation	NCT05512767	Clinical Stage ... Clinical Stage ... Clinical Stage ... Head and Neck C... Stage II Hypoph... Stage II Laryng... Stage II Lip an... Stage II Oropha... Stage III Hypop... Stage III Laryn... Stage III Lip a... Stage III Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Lip an... Stage IV Oropha...	Best Practice Consensus Audit... Diagnostic Imag... Lymphedema Mana... Modified Barium... Nasopharyngeal ... Pneumatic Compr... Quality-of-Life... Questionnaire A... Voice Handicap ...	18 Years -	Mayo Clinic
A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation	NCT05512767	Clinical Stage ... Clinical Stage ... Clinical Stage ... Head and Neck C... Stage II Hypoph... Stage II Laryng... Stage II Lip an... Stage II Oropha... Stage III Hypop... Stage III Laryn... Stage III Lip a... Stage III Oroph... Stage IV Hypoph... Stage IV Laryng... Stage IV Lip an... Stage IV Oropha...	Best Practice Consensus Audit... Diagnostic Imag... Lymphedema Mana... Modified Barium... Nasopharyngeal ... Pneumatic Compr... Quality-of-Life... Questionnaire A... Voice Handicap ...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for nasopharyngeal laryngoscopy