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

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03916068

Run by

Legacy Health System

People needed

1

Starts

2019-07-01

Expected to finish

2023-10-02

Last updated by the study team

2023-10-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• > 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

You may not qualify if…

• < 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

Where it is running

• Legacy Emanuel Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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