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

HBO001

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.

2019-07-01

2023-10-02

2023-10-02

Terminated

Early phase I

1

Inclusion Criteria: * \> 18 years of age * 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: * \< 18 years of age * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

2023-10-04