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

Recruitment & Eligibility

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 & Design

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen Therapy	Hyperbaric Oxygen Therapy	Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)
Trental and Vitamin E	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 and Vitamin E	Trental Pill	Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months

Primary Outcome Measures

Name	Time	Method
Change in breast fibrosis using Bakers Grade Assessment	Administered at week 1, week 7, week 13, week 25, week 53, and week 157.	The Bakers Grade Assessment will be used to evaluate if lower incidence and severity of radiation fibrosis is observed in patients receiving post-operative hyperbaric oxygen treatment as compared to Trental and Vitamin E. The difference-from-baseline (DFB) score will be calculated to determine the incidence and severity of radiation fibrosis. Some patients may develop radiation fibrosis at a later time so the assessment will be done multiple throughout the three years to capture timing of fibrosis onset.

Secondary Outcome Measures

Name	Time	Method
Objective measurements of tissue pliability using a Tissue Compliance Meter	Obtained at week 1, week 7, week 13, week 25, week 53, and week 157.
Patients' sense of well-being using SF-20 Quality of life survey.	Administered at week 1, week 7, week 13, week 25, week 53, and week 157.	Short Form 20 is a survey that patients complete to indicate their overall quality of life. The SF-20 is weighted and summed to provide easily interpretable scales for physical and mental health.
Pain in radiated breasts using a Visual Analog Scale	Administered at week 1, week 7, week 13, week 25, week 53, and week 157.	Visual Analog Scale is a way for patients to assess their pain, on a scale of one to ten with ten being worst pain imaginable.
Presence of delayed wound healing, surgical complications, implant revision or loss	Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157.

Recruitment & Eligibility