Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
NCT ID: NCT03916068
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2019-07-01
2023-10-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
NCT01349322
Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
NCT00002873
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
NCT02003209
Study of Stereotactic Radiotherapy for Breast Cancer
NCT03043794
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
NCT01266642
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hyperbaric Oxygen Therapy
Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)
Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
Trental and Vitamin E
Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months
Trental Pill
Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily
Vitamin E
Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
Trental Pill
Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily
Vitamin E
Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient is currently undergoing treatment for breast cancer and is on one of two pathways:
* Pathway 1 involves lumpectomy with radiation therapy, recurrence years later, mastectomy and tissue expander with further radiation therapy
* Pathway 2 involves mastectomy and tissue expander, 6 weeks of radiation therapy, and an implant in 6 months
* Undergone mastectomy with expander or implant reconstruction \> 2 weeks before starting radiation therapy
* Completed chest wall irradiation in the past 3 days
* Willing to stop herbal medications as directed by provider
* Willing to stop daily use of supplemental vitamin E (Multivitamin with vitamin E component is acceptable, vitamin E cream is also acceptable)
* Willing to have photographs of chest area taken for research purposes only
* Therapeutic PT-INR for participants taking Coumadin
* If tissue expanders remain intact during radiation, plan for conversion to the final implants must occur \> 4 months after completing radiation
* Willing to travel to a Legacy Health facility for study related visits
* Agree to attend study visits outside of standard of care visits, if needed
* Willing to engage in pre/post testing and survey/phone calls
* Willing to attend all 6 weeks of HBOT if randomized to that group
Exclusion Criteria
* Pregnant or lactating
* Have final implant placed \< 2 weeks before start of radiation therapy
* Plan to place final impacts \< 4 months from the completion of radiation therapy, if tissue expanders are intact during radiation therapy
* Have evidence of ongoing infection or implant exposure before start of radiation therapy
* Radiation completed more than 3 days prior to study start
* Unable to comply with protocol
* Unable to provide written informed consent
* Unwilling or unable to stop oral supplemental Vitamin E
* PT-INR outside of acceptable range for participants taking Coumadin
* Any delay in radiation treatment greater than 14 days
* Investigator does not believe study participation is in the best interest of the patient
* History of a seizure within the last 5 years
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Legacy Health System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Enoch Huang
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enoch Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Legacy Health System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Legacy Emanuel Medical Center
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HBO001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.