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临床试验/NCT01308944
NCT01308944已完成1 期

Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Feasibility of concurrent beta-blocker administration with chemotherapy

研究概览

简要总结

This research is looking at the effect of biobehavioral factors such as stress and whether these factors alter how the body responds to chemotherapy, one of the purposes of this study is to determine if the addition of a beta-blocker such as Propranolol (Inderal) is tolerable when given with chemotherapy in the treatment of newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer. An additional purpose of the study is to understand if behavioral factors such as depression and anxiety can alter different blood markers that affect tumor vascularity. The Investigator wishes to determine whether the use of beta-blocker drugs such as Inderal, might alter these behavioral factors by drawing blood prior to and after the administration of Inderal as well as giving behavioral questionaires at different time points. Beta-blockers are commonly used for the treatment of hypertension, protection of the heart after a heart attack, and irregularities in heartbeats. Altering these factors might boost the immune system and affect other areas of cancer biology, thereby allowing the chemotherapy to be more effective. The significance of this research is that it may help improve our treatments of this disease in the future.

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
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm 1

Experimental

Propranolol 40mg po orally twice daily to begin at least 48 hours prior to surgical debulking. This will ideally be titrated in order to maintain a heart rate between 60 and 80 without hypotension.

After surgery, the patient will resume the propranolol once tolerating clear liquids in the hospital and will remain on them until completion of chemotherapy.

After completion of chemotherapy, the patient will be weaned off the medication over the following two weeks.

干预措施: Propranolol (Drug)

结局指标

主要结局

Feasibility of concurrent beta-blocker administration with chemotherapy

时间窗: Completion of 6 cycles of chemotherapy/propranolol

Proportion of patients who successfully complete 6 cycles of chemotherapy and concurrent treatment with propranolol

次要结局

  • Progression free survival rates(From time of diagnosis to 1 year following the 6th cycle of chemotherapy or 18 months following surgery)
  • Pilot data on blood markers in patients with ovarian cancer pre- and post-beta blockade(Pre-surgery, Completion of 3rd cycle of chemo, Completion of 6th cycle of chemo)
  • Characterization of biobehavioral states with surveys(Pre-surgery, Completion of 3rd cycle of chemo, Completion of 2nd cycle of chemo)
  • Evaluation of immunohistochemistry of angiogenic markers on tumor samples(At time of initial surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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