Clinical trial NCT03916068: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Legacy Health System
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in breast fibrosis using Bakers Grade Assessment
timeFrame: Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Secondary outcomes:
measure: Objective measurements of tissue pliability using a Tissue Compliance Meter
timeFrame: Obtained at week 1, week 7, week 13, week 25, week 53, and week 157.
measure: Patients' sense of well-being using SF-20 Quality of life survey.
timeFrame: Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
measure: Pain in radiated breasts using a Visual Analog Scale
timeFrame: Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
measure: Presence of delayed wound healing, surgical complications, implant revision or loss
timeFrame: Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Emanuel Medical Center
state: Oregon
Study officials:
affiliation: Legacy Health System
name: Enoch Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: