Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT03916068

Recruitment Status:

Active, not recruiting

Sponsor:

Legacy Health System

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There is 1 Location for this study

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Legacy Emanuel Medical Center
Portland Oregon, 97227, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT03916068

Recruitment Status:

Active, not recruiting

Sponsor:


Legacy Health System

How clear is this clinincal trial information?

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