ConstipationNCT00536523
Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
An observational study of Constipation and Bowel Obstruction, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Constipation, Bowel Obstruction, Fallopian Tube Cancer
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer.
Who may be able to join
- Newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer
- Planned to undergo 6 courses of a taxane and platinum-containing regimen
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Constipation, Bowel Obstruction, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- Keywords
- constipation, impaction, and bowel obstruction, ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer
- Medical subject headings
- Constipation, Intestinal Obstruction, Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa A. Geller, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536523
- Sponsor's protocol ID
- 2007NT031
- Other IDs
- WCC-52
- Status last verified
- Aug 2014
- First submitted
- 27 Sep 2007
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation
- ClinicalTrials.gov ID
- NCT00536523
- Acronym / sponsor ID
- 2007NT031
- Conditions
- Constipation, Bowel Obstruction, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- Keywords
- constipation, impaction, and bowel obstruction, ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer.
Key inclusion criteria (2 listed)
- Newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer
- Planned to undergo 6 courses of a taxane and platinum-containing regimen
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alterations in serotonin levels associated with increased constipation
Time frame: PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment
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.
Results and safety
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa A. Geller, MD study chair
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Bowel Obstruction, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in serotonin levels associated with increased constipation (time frame: PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.