Constipation in Pediatric Cancer Patients Receiving Vinca Alkaloids or Narcotics

NCT00032682 | Completed

• 2 other identifiers: 02014602-CC-0146
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Constipation; Neoplasms

Keywords

Bowel Movement; Children; Stool; Symptom Management; Cancer; Constipation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Robinson CB, Fritch M, Hullett L, Petersen MA, Sikkema S, Theuninck L, Timmer K. Development of a protocol to prevent opioid-induced constipation in patients with cancer: a research utilization project. Clin J Oncol Nurs. 2000 Mar-Apr;4(2):79-84.

  PMID: 11107380 BACKGROUND

• Kavanagh JJ, Copeland LJ, Gershenson DM, Saul PB, Wharton JT, Rutledge FN. Continuous-infusion vinblastine in refractory carcinoma of the cervix: a phase II trial. Gynecol Oncol. 1985 Jun;21(2):211-4. doi: 10.1016/0090-8258(85)90254-9.

  PMID: 3988134 BACKGROUND

• Wright PS, Thomas SL. Constipation and diarrhea: the neglected symptoms. Semin Oncol Nurs. 1995 Nov;11(4):289-97. doi: 10.1016/s0749-2081(05)80010-5.

  PMID: 8578037 BACKGROUND

MeSH Terms

Conditions

Constipation; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 27, 2002
• First Posted: March 28, 2002
• Study Start: March 1, 2002
• Study Completion: April 1, 2006
• Last Updated: March 4, 2008

Record last verified: 2006-04

Locations

US (1)