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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- Masonic Cancer Center at University of Minnesota
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Alterations in serotonin levels associated with increased constipation
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Melissa A. Geller, MD, Masonic Cancer Center, University of Minnesota
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2007NT031
- WCC-52 (Annan identifierare: Women's Cancer Center, University of Minnesota)
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