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

Legacy Health System

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: Hyperbaric Oxygen Therapy; Dietary Supplement: Vitamin E; Drug: Trental Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT03916068

HBO001

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Hyperbaric Oxygen Therapy

Experimental group

Description:

Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)

Treatment:

Procedure: Hyperbaric Oxygen Therapy

Trental and Vitamin E

Active Comparator group

Description:

Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months

Treatment:

Drug: Trental Pill

Dietary Supplement: Vitamin E