Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-02-08 @ 8:21 PM
Study NCT ID:
NCT03916068
Status:
TERMINATED
Last Update Posted:
2023-10-04
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}, {'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Insufficient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in breast fibrosis using Bakers Grade Assessment', 'timeFrame': 'Administered at week 1, week 7, week 13, week 25, week 53, and week 157.', 'description': 'The Bakers Grade Assessment will be used to evaluate if lower incidence and severity of radiation fibrosis is observed in patients receiving post-operative hyperbaric oxygen treatment as compared to Trental and Vitamin E. The difference-from-baseline (DFB) score will be calculated to determine the incidence and severity of radiation fibrosis. Some patients may develop radiation fibrosis at a later time so the assessment will be done multiple throughout the three years to capture timing of fibrosis onset.'}], 'secondaryOutcomes': [{'measure': 'Objective measurements of tissue pliability using a Tissue Compliance Meter', 'timeFrame': 'Obtained at week 1, week 7, week 13, week 25, week 53, and week 157.'}, {'measure': "Patients' sense of well-being using SF-20 Quality of life survey.", 'timeFrame': 'Administered at week 1, week 7, week 13, week 25, week 53, and week 157.', 'description': 'Short Form 20 is a survey that patients complete to indicate their overall quality of life. The SF-20 is weighted and summed to provide easily interpretable scales for physical and mental health.'}, {'measure': 'Pain in radiated breasts using a Visual Analog Scale', 'timeFrame': 'Administered at week 1, week 7, week 13, week 25, week 53, and week 157.', 'description': 'Visual Analog Scale is a way for patients to assess their pain, on a scale of one to ten with ten being worst pain imaginable.'}, {'measure': 'Presence of delayed wound healing, surgical complications, implant revision or loss', 'timeFrame': 'Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to compare patients that receive hyperbaric oxygen or Trental and Vitamin E immediately after completion of radiation therapy to evaluate which treatment best reduces radiation fibrosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age\n* Patient is currently undergoing treatment for breast cancer and is on one of two pathways:\n\n * Pathway 1 involves lumpectomy with radiation therapy, recurrence years later, mastectomy and tissue expander with further radiation therapy\n * Pathway 2 involves mastectomy and tissue expander, 6 weeks of radiation therapy, and an implant in 6 months\n* Undergone mastectomy with expander or implant reconstruction \\> 2 weeks before starting radiation therapy\n* Completed chest wall irradiation in the past 3 days\n* Willing to stop herbal medications as directed by provider\n* Willing to stop daily use of supplemental vitamin E (Multivitamin with vitamin E component is acceptable, vitamin E cream is also acceptable)\n* Willing to have photographs of chest area taken for research purposes only\n* Therapeutic PT-INR for participants taking Coumadin\n* If tissue expanders remain intact during radiation, plan for conversion to the final implants must occur \\> 4 months after completing radiation\n* Willing to travel to a Legacy Health facility for study related visits\n* Agree to attend study visits outside of standard of care visits, if needed\n* Willing to engage in pre/post testing and survey/phone calls\n* Willing to attend all 6 weeks of HBOT if randomized to that group\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* Pregnant or lactating\n* Have final implant placed \\< 2 weeks before start of radiation therapy\n* Plan to place final impacts \\< 4 months from the completion of radiation therapy, if tissue expanders are intact during radiation therapy\n* Have evidence of ongoing infection or implant exposure before start of radiation therapy\n* Radiation completed more than 3 days prior to study start\n* Unable to comply with protocol\n* Unable to provide written informed consent\n* Unwilling or unable to stop oral supplemental Vitamin E\n* PT-INR outside of acceptable range for participants taking Coumadin\n* Any delay in radiation treatment greater than 14 days\n* Investigator does not believe study participation is in the best interest of the patient\n* History of a seizure within the last 5 years'}, 'identificationModule': {'nctId': 'NCT03916068', 'briefTitle': 'Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Legacy Health System'}, 'officialTitle': 'A Pilot Study Comparing Acute Post-Radiation Hyperbaric Oxygen (HBO2) Versus Trental and Vitamin E for Breast Cancer Patients Who Have Recently Completed Radiation Therapy as Part of Their Treatment Course', 'orgStudyIdInfo': {'id': 'HBO001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric Oxygen Therapy', 'description': 'Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)', 'interventionNames': ['Procedure: Hyperbaric Oxygen Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trental and Vitamin E', 'description': 'Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months', 'interventionNames': ['Drug: Trental Pill', 'Dietary Supplement: Vitamin E']}], 'interventions': [{'name': 'Hyperbaric Oxygen Therapy', 'type': 'PROCEDURE', 'description': 'Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.', 'armGroupLabels': ['Hyperbaric Oxygen Therapy']}, {'name': 'Trental Pill', 'type': 'DRUG', 'otherNames': ['pentoxifylline'], 'description': 'Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily', 'armGroupLabels': ['Trental and Vitamin E']}, {'name': 'Vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily', 'armGroupLabels': ['Trental and Vitamin E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Emanuel Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Enoch Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Legacy Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Legacy Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Enoch Huang', 'investigatorAffiliation': 'Legacy Health System'}}}}