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

• ClinicalTrials.gov Identifier: NCT03916068
• Recruitment Status: Active, not recruiting
• First Posted: April 16, 2019
• Last Update Posted: August 16, 2022
• Sponsor: Legacy Health System
• Information provided by (Responsible Party): Enoch Huang, Legacy Health System

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: Hyperbaric Oxygen Therapy; Drug: Trental Pill; Dietary Supplement: Vitamin E	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: July 1, 2019
• Estimated Primary Completion Date: May 1, 2023
• Estimated Study Completion Date: May 1, 2024

Arms and Interventions

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 Name: pentoxifylline; Dietary Supplement: Vitamin E; Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily

Outcome Measures

Primary Outcome Measures :

1. Change in breast fibrosis using Bakers Grade Assessment [ Time Frame: 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 :

1. 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. ]
2. Patients' sense of well-being using SF-20 Quality of life survey. [ Time Frame: 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.
3. Pain in radiated breasts using a Visual Analog Scale [ Time Frame: 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.
4. 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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Oregon

Legacy Emanuel Medical Center

Portland, Oregon, United States, 97227

Sponsors and Collaborators

Legacy Health System

Investigators

• Principal Investigator: Enoch Huang, MD; Legacy Health System

More Information

• Responsible Party: Enoch Huang, Principal Investigator, Legacy Health System
• ClinicalTrials.gov Identifier: NCT03916068
• Other Study ID Numbers: HBO001
• First Posted: April 16, 2019
• Last Update Posted: August 16, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Breast Neoplasms; Breast Diseases; Neoplasms by Site; Neoplasms; Skin Diseases; Vitamin E; Pentoxifylline; Vitamins; Micronutrients; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Radiation-Protective Agents; Vasodilator Agents; Free Radical Scavengers