NCT00536523

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

2.7 years

First QC Date

September 27, 2007

Last Update Submit

August 21, 2014

Conditions

ConstipationBowel ObstructionFallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer

Keywords

constipation, impaction, and bowel obstructionovarian epithelial cancerperitoneal cavity cancerfallopian tube cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer.

You may qualify if:

  • Newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer
  • Planned to undergo 6 courses of a taxane and platinum-containing regimen

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

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.

MeSH Terms

Conditions

ConstipationIntestinal ObstructionFallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Melissa A. Geller, MD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2007

First Posted

September 28, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

US(1)