Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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.
Fallopian Tube Cancer
Peritoneal Cavity Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation|
- Alterations in serotonin levels associated with increased constipation [ Time Frame: PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
A blood sample (5 ml red top tube) will be drawn before the patient's first chemotherapy treatment, after the 3rd cycle of chemotherapy, at the post chemotherapy follow-up visit (approximately 30 days after chemotherapy is completed) and approximately 4 months after completion of chemotherapy at the time of a routine follow-up visit. Whenever possible, the blood will be drawn at the same time blood is being collected for clinical purposes therefore flexibility is allowed in the timing of the research related bloods.
|Study Start Date:||April 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536523
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Melissa A. Geller, MD||Masonic Cancer Center, University of Minnesota|