Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Mean change from baseline to highest Hgb value
研究概览
简要总结
This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.
详细描述
This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection. The concomitant use of radiation and immunotherapy as part of the neoadjuvant protocol is allowed in this protocol. The study is designed to evaluate the efficacy of iron infusions in reducing blood transfusion frequency and improving hemoglobin levels prior to surgical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 18 years
- •Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies.
- •Anemia defined as Hgb <10.5 g/dL during chemotherapy.
- •Iron storage levels of ferritin <500 ng/mL and iron saturation <35%
- •Ability to understand and willingness to sign a written informed consent and HIPAA consent document
排除标准
- •Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb < 11.0 g/dL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new/exacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Prior parenteral iron infusion in the past 4 weeks
- •The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD
- •Concurrent systemic infection at the time of enrollment.
- •Known hypersensitivity to Iron sucrose
- •Pregnant or breast feeding. Refer to section 4.4 for further detail.
- •Anemia from another established etiology (i.e MDS, Myeloma)
研究组 & 干预措施
Venofer treatment
Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion
干预措施: Venofer (Drug)
结局指标
主要结局
Mean change from baseline to highest Hgb value
时间窗: 6 weeks
To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia by improving the hemoglobin of patients undergoing neoadjuvant chemotherapy. Mean change from baseline to highest Hgb value observed six weeks after last iron infusion, before day of surgery.
次要结局
- Number of transfusions during neo-adjuvant period(24 weeks)