Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Alterations in serotonin levels associated with increased constipation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer
- •Planned to undergo 6 courses of a taxane and platinum-containing regimen
排除标准
- •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
结局指标
主要结局
Alterations in serotonin levels associated with increased constipation
时间窗: PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment
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.
次要结局
未报告次要终点