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

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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

Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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. ]
  • 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.
  • 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.
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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. ]
  • Patients' sense of well-being using SF-12 Quality of life survey. [ Time Frame: Administered at week 1, week 7, week 13, week 25, week 53, and week 157. ]
    Short Form 12 is a survey that patients complete to indicate their overall quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.
  • 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.
  • 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Procedure: Hyperbaric Oxygen Therapy
    Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
  • 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
Study Arms  ICMJE
  • Experimental: Hyperbaric Oxygen Therapy
    Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)
    Intervention: Procedure: Hyperbaric Oxygen Therapy
  • 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
    Interventions:
    • Drug: Trental Pill
    • Dietary Supplement: Vitamin E
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2024
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lauren Elliott 503-413-8199 oncologyresearch@lhs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03916068
Other Study ID Numbers  ICMJE HBO001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Enoch Huang, Legacy Health System
Study Sponsor  ICMJE Legacy Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Enoch Huang, MD Legacy Health System
PRS Account Legacy Health System
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP