Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Legacy Health System
• Treatments: alpha-Tocopherol; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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