Constipation in Pediatric Cancer Patients Receiving Vinca Alkaloids or Narcotics

Completed

Conditions studied: Constipation, Neoplasms

In brief

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.

Key facts

Study ID

NCT00032682

Run by

National Institutes of Health Clinical Center (CC)

People needed

34

Starts

2002-03-01

Expected to finish

2006-04-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NCI patients less than or equal to 21 years of age
• Diagnosis of histologically confirmed cancer
• Receiving: weekly vinca alkaloids and/or narcotics greater than or equal to 2 times per day (includes patient controlled analgesia, transdermal analgesic patches)
• ECOG performance score of less than or equal to 2
• Patients, parents, or legal guardian must be able to speak and read English
• Informed consent: All patients or their legal guardians (if patient is less than 18 years of age) must sign a document of informed consent indicating their understanding of the purpose of this study and the risks associated with participation. Pediatric patients less than 18 years of age will be included in all discussions. Written assent will be obtained in children less than 18 and greater than or equal to 8 years of age. Verbal assent will be obtained in children less than 8 years of age when possible.

You may not qualify if…

• Unable to provide consent/assent
• Patients with acute life threatening infection or bowel obstruction
• Patients with inevaluable bowel function (i.e. patients with a colostomy or paralyzed patients)
• Patients previously enrolled on this study.

Where it is running

• National Institutes of Health Clinical Center (CC) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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