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

A Pilot Study Comparing Acute Post-Radiation Hyperbaric Oxygen (HBO2) Versus Trental and Vitamin E for Breast Cancer Patients Who Have Recently Completed Radiation Therapy as Part of Their Treatment Course

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Hyperbaric Oxygen Therapy; Drug: Trental Pill; Dietary supplement: Vitamin E

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric Oxygen Therapy; Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)	Procedure: Hyperbaric Oxygen Therapy; Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
Active Comparator: Trental and Vitamin E; Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months	Drug: Trental Pill; Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily; Other Names: pentoxifylline; Dietary supplement: Vitamin E; Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in breast fibrosis using Bakers Grade Assessment	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.	Administered at week 1, week 7, week 13, week 25, week 53, and week 157.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Pain in radiated breasts using a Visual Analog Scale	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.	Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
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.

Collaborators and Investigators

• Sponsor: Legacy Health System
• Investigators: Principal Investigator: Enoch Huang, MD, Legacy Health System

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Micronutrients; Vitamins; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Vitamin E; Pentoxifylline
• Other Study ID Numbers: HBO001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes