Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation
RATIONALE: Gathering information about changes in serotonin levels in patients undergoing chemotherapy for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer may help doctors learn more about constipation caused by chemotherapy.
PURPOSE: This clinical trial is studying how blood levels of serotonin effect constipation caused by chemotherapy in patients with newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
研究概览
详细说明
OBJECTIVES:
- To determine if there are any alterations in serotonin levels in patients undergoing chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer and if this is associated with increased constipation.
OUTLINE: Patients undergo blood sample collection prior to beginning of planned postoperative chemotherapy, after 3 and 6 courses of chemotherapy, and at the 3-month surveillance visit. Patients also complete a bowel function questionnaire at these time points.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55455
- Masonic Cancer Center at University of Minnesota
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer
- Planned to undergo 6 courses of a taxane and platinum-containing regimen
Exclusion Criteria:
- Ovarian low malignant potential tumor
- History of constipation or irritable bowel syndrome
- History of colorectal cancer
- Prior bowel resection at time of staging/cytoreductive surgery
- Prior abdominal-pelvic radiation
- Prior bowel surgery
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Patients Receiving Chemotherapy
Patients with newly diagnosed ovarian, fallopian tube or primary peritoneal cancer for which 6 cycles of a taxane and platinum containing regimen is planned
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Alterations in serotonin levels associated with increased constipation
大体时间：PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment
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Once the blood is drawn at the time of another necessary blood draw, the specimen will be labeled as a send out lab in the acute care lab.
These are frozen and batched.
Batched samples will then be sent to an outside laboratory for serotonin measurements.
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PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment
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合作者和调查者
调查人员
- 学习椅：Melissa A. Geller, MD、Masonic Cancer Center, University of Minnesota
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.