Breast Cancer Clinical Trial
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
Verified date | October 2023 |
Source | Legacy Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | October 2, 2023 |
Est. primary completion date | October 2, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Legacy Emanuel Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Legacy Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Secondary | 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. | ||
Secondary | 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. | Administered at week 1, week 7, week 13, week 25, week 53, and week 157. | |
Secondary | 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. | |
Secondary | 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. |
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