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NCT00032682 · ClinicalTrials.gov registry record

Constipation in Pediatric Cancer Patients Receiving Vinca Alkaloids or Narcotics

A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
34
Enrollment target

NCT00032682: Completed study, sponsored by National Institutes of Health Clinical Center (CC).

NCT00032682 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00032682 has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
34 participants
Enrollment target

Study Summary

This study will evaluate a questionnaire for measuring constipation in children with cancer. The questionnaire used in this study (Constipation Assessment Scale) reliably predicts the presence and severity of constipation in adult patients, but has not been tested in children. The answers to the questionnaire will be used to determine the child's level of constipation and to plan and provide appropriate care. Patients up to 21 years of age who are enrolled in National Cancer Institute trials and are taking weekly vinca alkaloids or narcotics twice a day or more may be eligible for this study. On admission to the study, participants will undergo the following procedures: * The child (or the child's parent) will be interviewed about the child's bowel habits. * The results of the child's most recent physical examination related to bowel function will be obtained from the medical record for review. * A registered dietitian will interview the child or parent about the child's eating habits. During the study, participants will undergo the following procedures: * A registered nurse will interview the child or parent about the child's bowel movements. This will be done every other day for hospitalized children and three times a week (by phone) for outpatients. * The child or parent will complete a daily diary of bowel movements. * A registered dietitian will evaluate the child's nutritional status periodically (by phone). Children who are not constipated when they enter the study will receive a stool softener every day to prevent constipation. Children who become constipated during the study will be treated as needed. Patients will be followed for 7 days after the last dose of vinca alkaloid or narcotic for a maximum of 6 weeks.

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2002-03
Est. Completion 2006-04

What the finished NCT00032682 record still lists

NCT00032682 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00032682 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00032682 about?

NCT00032682 is a clinical study titled "Constipation in Pediatric Cancer Patients Receiving Vinca Alkaloids or Narcotics". This study will evaluate a questionnaire for measuring constipation in children with cancer. The questionnaire used in this study (Constipation Assessment Scale) reliably predicts the presence and severity of constipation in adult patients, but has not been tested in children. The answers to the que...

What is the current status of trial NCT00032682?

This trial is currently completed. The enrollment target is 34 participants. The study started on 2002-03. Estimated completion is 2006-04.

Who is sponsoring clinical trial NCT00032682?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00032682, the US trial registry maintained by the National Library of Medicine. NCT00032682 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.