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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Trental Pill
Vitamin E
Sponsored by
Legacy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Legacy Emanuel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyperbaric Oxygen Therapy

Trental and Vitamin E

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Objective measurements of tissue pliability using a Tissue Compliance Meter
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.
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.
Presence of delayed wound healing, surgical complications, implant revision or loss

Full Information

First Posted
April 4, 2019
Last Updated
October 2, 2023
Sponsor
Legacy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03916068
Brief Title
Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
October 2, 2023 (Actual)
Study Completion Date
October 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric Oxygen Therapy
Arm Type
Experimental
Arm Description
Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)
Arm Title
Trental and Vitamin E
Arm Type
Active Comparator
Arm Description
Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
Intervention Type
Drug
Intervention Name(s)
Trental Pill
Other Intervention Name(s)
pentoxifylline
Intervention Description
Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Intervention Description
Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily
Primary Outcome Measure Information:
Title
Change in breast fibrosis using Bakers Grade Assessment
Description
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.
Time Frame
Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Secondary Outcome Measure Information:
Title
Objective measurements of tissue pliability using a Tissue Compliance Meter
Time Frame
Obtained at week 1, week 7, week 13, week 25, week 53, and week 157.
Title
Patients' sense of well-being using SF-20 Quality of life survey.
Description
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.
Time Frame
Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Title
Pain in radiated breasts using a Visual Analog Scale
Description
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.
Time Frame
Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Title
Presence of delayed wound healing, surgical complications, implant revision or loss
Time Frame
Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enoch Huang, MD
Organizational Affiliation
Legacy Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Emanuel Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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