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Constipation in Pediatric Cancer Patients Receiving Vinca Alkaloids or Narcotics

NCT00032682 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2008-03-04

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Completion
2006-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00032682 on ClinicalTrials.gov