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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in breast fibrosis using Bakers Grade Assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •> 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
排除标准
- •< 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
研究组 & 干预措施
Hyperbaric Oxygen Therapy
Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)
干预措施: Hyperbaric Oxygen Therapy (Procedure)
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
干预措施: Trental Pill (Drug)
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
干预措施: Vitamin E (Dietary Supplement)
结局指标
主要结局
Change in breast fibrosis using Bakers Grade Assessment
时间窗: 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.
次要结局
- 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.(Administered at week 1, week 7, week 13, week 25, week 53, and week 157.)
- Pain in radiated breasts using a Visual Analog Scale(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.)
研究者
Enoch Huang
Principal Investigator
Legacy Health System