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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916068
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Enoch Huang, Legacy Health System

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

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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, 2021
Estimated Study Completion Date : May 1, 2024


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




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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916068


Contacts
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Contact: Lauren Elliott 503-413-8199 oncologyresearch@lhs.org

Locations
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United States, Oregon
Legacy Emanuel Medical Center Recruiting
Portland, Oregon, United States, 97227
Contact: Lauren Elliott    503-413-8199    lelliott@lhs.org   
Contact: Leslie Sorenson    503-413-8199    lmsorens@lhs.org   
Principal Investigator: Enoch Huang, MD         
Sponsors and Collaborators
Legacy Health System
Investigators
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Principal Investigator: Enoch Huang, MD Legacy Health System
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Responsible Party: Enoch Huang, Principal Investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT03916068    
Other Study ID Numbers: HBO001
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamin E
Pentoxifylline
Vitamins
Micronutrients
Nutrients
Growth Substances
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