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| ID | Type | Description | Link |
|---|---|---|---|
| WCC-52 | Other Identifier | Women's Cancer Center, University of Minnesota |
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Funding unavailable
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Alterations in serotonin levels associated with increased constipation | 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. | PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Women with newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa A. Geller, MD | Masonic Cancer Center, University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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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.
| ID | Term |
|---|---|
| D003248 | Constipation |
| D007415 | Intestinal Obstruction |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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