Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05512767
Status:
WITHDRAWN
Last Update Posted:
2023-01-06
First Post:
2022-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI retired and study not moving forward', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-08-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare composite measurements of the face and neck for lymphatic drainage', 'timeFrame': 'Change from baseline and up to 12 weeks', 'description': '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.'}, {'measure': 'Change in lymphedema of the head and neck', 'timeFrame': 'Up to 12 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Improvements on quality of life (QOL) function', 'timeFrame': 'Up to 12 weeks', 'description': 'Measured by QOL questionnaire and Facial and Neck Composite Measurements\n\nStatus Scale:\n\nPSS-HN'}, {'measure': 'Improvements on voice function', 'timeFrame': 'Up to 12 weeks', 'description': 'Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V'}, {'measure': 'Improvements on swallowing function', 'timeFrame': 'Up to 12 weeks', 'description': 'Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'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']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. 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.\n\nII. Assess compliance of treatment in both groups. III. Assess changes in voice and swallowing in both groups.\n\nOUTLINE: Patients are assigned to 1 of 2 groups.\n\nGROUP 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.\n\nGROUP 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent\n* Cognitive function adequate to understand and execute the elements of the protocol\n* Willingness and ability to return to Mayo Clinic for follow-up care per protocol\n* Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)\n* Must demonstrate oropharyngeal competency that would allow some oral intake\n\nExclusion Criteria:\n\n* Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer\n* Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative\n* Acute facial infection\n* Active congestive heart failure (CHF) or pulmonary edema\n* Symptomatic carotid artery disease or bradycardia\n* Increased intracranial pressure\n* History of multiple cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs)\n* \\> 50% internal carotid artery (ICA) blockage\n* Upper quadrant deep vein thrombosis\n* Known esophageal obstruction\n* Percutaneous endoscopic gastrostomy (PEG) tube dependence with no oral intake\n* Women of child-bearing potential\n* (Active) pregnancy'}, 'identificationModule': {'nctId': 'NCT05512767', 'briefTitle': 'A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population', 'orgStudyIdInfo': {'id': '21-003342'}, 'secondaryIdInfos': [{'id': 'NCI-2022-06767', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (pneumatic therapy, lymphedema management)', 'description': '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.', 'interventionNames': ['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']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (standard of care, lymphedema management)', 'description': '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.', 'interventionNames': ['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': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Undergo self-manual lymphatic drainage', 'armGroupLabels': ['Group II (standard of care, lymphedema management)']}, {'name': 'Consensus Auditory-Perceptual Evaluation of Voice', 'type': 'OTHER', 'otherNames': ['CAPE-V', 'Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)', 'Group II (standard of care, lymphedema management)']}, {'name': 'Diagnostic Imaging', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging'], 'description': 'Undergo photographs of face and neck', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)', 'Group II (standard of care, lymphedema management)']}, {'name': 'Lymphedema Management', 'type': 'OTHER', 'description': 'Undergo skilled lymphedema treatment by a therapist', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)', 'Group II (standard of care, lymphedema management)']}, {'name': 'Modified Barium Swallow', 'type': 'PROCEDURE', 'otherNames': ['MBS', 'VFSS', 'Videofluoroscopic Swallowing Study'], 'description': 'Undergo swallow study', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)', 'Group II (standard of care, lymphedema management)']}, {'name': 'Nasopharyngeal Laryngoscopy', 'type': 'PROCEDURE', 'description': 'Undergo Nasolaryngoscopy', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)', 'Group II (standard of care, lymphedema management)']}, {'name': 'Pneumatic Compression Therapy', 'type': 'DEVICE', 'otherNames': ['Flexi-touch Plus System'], 'description': '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.', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)', 'Group II (standard of care, lymphedema management)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)', 'Group II (standard of care, lymphedema management)']}, {'name': 'Voice Handicap Index-10', 'type': 'OTHER', 'otherNames': ['VHI-10', 'Voice Handicap Index-10 (VHI-10)'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (pneumatic therapy, lymphedema management)', 'Group II (standard of care, lymphedema management)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lisa Crujido', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}