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

NCT03916068 | Terminated Phase 2 FDA Drug

• 1 other identifier: HBO001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• Pain in radiated breasts using a Visual Analog Scale

  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.

Study Arms (2)

Hyperbaric Oxygen Therapy

EXPERIMENTAL

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

Procedure: Hyperbaric Oxygen Therapy

Trental and Vitamin E

ACTIVE COMPARATOR

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; Dietary Supplement: Vitamin E

Interventions

Hyperbaric Oxygen Therapy PROCEDURE

Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.

Hyperbaric Oxygen Therapy

Trental Pill DRUG

Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily

Also known as: pentoxifylline

Trental and Vitamin E

Vitamin E DIETARY_SUPPLEMENT

Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily

Trental and Vitamin E

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Legacy Health System: lead

Study Sites (1)

Legacy Emanuel Medical Center

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hyperbaric Oxygenation; Pentoxifylline; Vitamin E

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Enoch Huang, MD

  Legacy Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 16, 2019
• Study Start: July 1, 2019
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)