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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks) |
|
| Trental and Vitamin E | Active Comparator | Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | Procedure | Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Administered at week 1, week 7, week 13, week 25, week 53, and week 157. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective measurements of tissue pliability using a Tissue Compliance Meter | 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. |
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Inclusion Criteria:
> 18 years of age
Patient is currently undergoing treatment for breast cancer and is on one of two pathways:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Enoch Huang, MD | Legacy Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Emanuel Medical Center | Portland | Oregon | 97227 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| D010431 | Pentoxifylline |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D013805 | Theobromine |
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| Trental Pill | Drug | Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily |
|
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| Vitamin E | Dietary Supplement | Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily |
|
| 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. | 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 | Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D014970 |
| Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |