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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1
Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily
Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily
Legacy Emanuel Medical Center
Portland, Oregon, United States
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.
Time frame: Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
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.
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.
Time frame: Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Pain in radiated breasts using a Visual Analog Scale
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.
Time frame: 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
Time frame: Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157.
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