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Search/NCT00032682
NCT00032682N/ACompleted

A Pilot Study Evaluating the Assessment Process for Constipation in Pediatric Oncology Patients Who Are Receiving Vinca Alkaloids and/or Narcotics

National Institutes of Health Clinical Center (CC)·observational·Posted Mar 28, 2002·Updated Mar 4, 2008

In Brief

An observational study for Constipation and Neoplasms. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2002
Enrollment StartMar 1, 2002
Study CompletionApr 1, 2006
TodayJul 2, 2026
Posted 24.3 years ago