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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- Masonic Cancer Center at University of Minnesota
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Alterations in serotonin levels associated with increased constipation
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Melissa A. Geller, MD, Masonic Cancer Center, University of Minnesota
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2007NT031
- WCC-52 (Annen identifikator: Women's Cancer Center, University of Minnesota)
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