Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 7:39 PM
Study NCT ID:
NCT05937269
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-09
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-29', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence/Severity of lymphedema', 'timeFrame': 'Enrollment', 'description': 'The incidence of lymphedema between the control and treated groups will be compared.'}, {'measure': 'Incidence/Severity of lymphedema', 'timeFrame': '3 months', 'description': 'The incidence of lymphedema between the control and treated groups will be compared.'}, {'measure': 'Incidence/Severity of lymphedema', 'timeFrame': '6 months', 'description': 'The incidence of lymphedema between the control and treated groups will be compared.'}, {'measure': 'Incidence/Severity of lymphedema', 'timeFrame': '12 months', 'description': 'The incidence of lymphedema between the control and treated groups will be compared.'}], 'secondaryOutcomes': [{'measure': 'Change in area of dermal lymphatic backflow', 'timeFrame': '3 months', 'description': 'The change (from enrollment) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.'}, {'measure': 'Change in area of dermal lymphatic backflow', 'timeFrame': '6 months', 'description': 'The change (from 3 months) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.'}, {'measure': 'Change in area of dermal lymphatic backflow', 'timeFrame': '12 months', 'description': 'The change (from 6 months) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['indocyanine green imaging', 'head and neck cancer-acquired lymphedema', 'near-infrared fluorescence lymphatic imaging', 'advanced pneumatic compression therapy'], 'conditions': ['Lymphedema of Face', 'Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if treating the lymphatics in head and neck cancer survivors before clinical diagnosis of lymphedema will prevent its development or progression. The main questions it aims to answer are:\n\n* Does early lymphatic treatment, before onset of clinical symptoms, prevent the development of head and neck lymphedema?\n* Does dermal lymphatic backflow provide an early indication of lymphedema and its response to treatment?\n\nOver the course of one year, participants will undergo several sessions near-infrared fluorescence lymphatic imaging to assess whether they have abnormal dermal lymphatic backflow following head and neck cancer treatment. Subjects will be divided into two groups, a treated and a control group. The treated group will be asked to complete daily sessions of pneumatic compression therapy at home, while the control group will receive standard-of-card treatment after clinical diagnosis of lymphedema. Researchers will compare the incidence of lymphedema between the two groups to see if treatment before diagnosis prevents the development and progression of head and neck lymphedema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be 18 years of age or older\n* Participants must have previously been diagnosed with head and neck cancer and undergone surgery and radiation as part of their standard-of-care treatment plan\n* Participants must be ≥ 4 weeks but less than 3 months post-radiation therapy at enrollment\n* Female participants of childbearing potential must have a negative urine pregnancy test ≤ 36 hours prior to study drug administration\n* Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month after each imaging session\n* Male participants must agree to shave facial hair on imaging days\n* Participants must be willing and able to independently use the pneumatic compression device at home daily for up to 12 months as directed by study personnel.\n\nExclusion Criteria:\n\n* Persons who are pregnant or breast-feeding\n* Females of child-bearing potential, who do not agree to use an approved contraceptive for one month after each imaging session\n* Persons who do not meet inclusion criteria\n* Iodine allergy\n* Persons with a chest circumference of 150 cm or more\n* Uncontrolled hyperthyroidism or parathyroidism (for which an endocrinologist recommends against neck compression)\n* Carotid sinus hypersensitivity syndrome\n* Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke or amaurosis fugax (monocular visual ischemic symptoms or blindness)\n* Symptomatic bradycardia in the absence of a pacemaker or internal jugular venous thrombosis (within 3 months)\n* Increased intracranial pressure or other contraindication to internal or external jugular venous compression\n* Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6 to 8-weeks post-operative\n* Facial or head and neck dermal metastasis\n* Acute facial infection (e.g., facial, or parotid gland abscess)\n* Heart failure (acute pulmonary edema, decompensated acute heart failure)\n* Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)\n* Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)\n* Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin, or untreated inflammatory skin disease)\n* Any condition where increased venous and lymphatic return is undesirable'}, 'identificationModule': {'nctId': 'NCT05937269', 'briefTitle': 'Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck', 'orgStudyIdInfo': {'id': 'HSC-MS-23-0268'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advanced Pneumatic Compression', 'description': 'Subjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home.', 'interventionNames': ['Combination Product: Near-infrared fluorescence lymphatic imaging', 'Device: advanced pneumatic compression therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-of-Care', 'description': 'Subjects who present with dermal lymphatic backflow will continue under standard-of-care surveillance of lymphedema and will only receive treatment if they are diagnosed with head and neck cancer-acquired lymphedema.', 'interventionNames': ['Combination Product: Near-infrared fluorescence lymphatic imaging']}, {'type': 'OTHER', 'label': 'No Dermal Backflow', 'description': 'Subjects who do not present with dermal lymphatic backflow at enrollment will be monitored at subsequent visits and if/when dermal lymphatic backflow is observed will be randomized into either Advanced Pneumatic Compression or Standard-of-Care arm.', 'interventionNames': ['Combination Product: Near-infrared fluorescence lymphatic imaging']}], 'interventions': [{'name': 'Near-infrared fluorescence lymphatic imaging', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['indocyanine green imaging'], 'description': 'All subjects will undergo lymphatic imaging at enrollment, 3, 6, and 12 months to assess the extent of dermal lymphatic backflow. Small amounts (0.1 mL) of a solution of indocyanine green (ICG) will be intradermally injected near the ear and along the jaw. Images of the lymphatics will be acquired by shining a dim light on the face and neck and acquiring the resulting fluorescent signal emanating from ICG-laden lymph. Images will be processed to calculate the area of the head and neck that show abnormal dermal lymphatic backflow.', 'armGroupLabels': ['Advanced Pneumatic Compression', 'No Dermal Backflow', 'Standard-of-Care']}, {'name': 'advanced pneumatic compression therapy', 'type': 'DEVICE', 'description': 'The advanced pneumatic compression device (APCD) mimics manual lymphatic drainage, a light massage that stimulates lymphatic uptake and function and frequently prescribed for lymphedema therapy.', 'armGroupLabels': ['Advanced Pneumatic Compression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'John Rasmussen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be published in a scientific journal along with description of protocol. The complete data set includes large (GBs) sequences of images as well as protected health information (faces). Partial, redacted data sets may be sharable upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'John Rasmussen', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}