Protocol Number: 02-CC-0146

Title:

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

Number:

02-CC-0146

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.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Special Instructions: Currently Not Provided

Keywords:

Bowel Movement

Children

Stool

Symptom Management

Recruitment Keywords:

Cancer

Constipation

Children

Stool

Conditions:

Constipation

Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Robinson CB, Fritch M, Hullett L, Petersen MA, Sikkema S, Theuninck L,Timmer K Development of a protocol to prevent opioid-induced constipation in patientswith cancer: a research utilization project Clin J Oncol Nurs 2000 Mar-Apr;4(2):79-84 PMID: 11107380

Kavanagh JJ, Copeland LJ, Gershenson DM, Saul PB, Wharton JT, Rutledge FN Continuous-infusion vinblastine in refractory carcinoma of the cervix: a phaseII trial Gynecol Oncol 1985 Jun;21(2):211-4 PMID: 3988134

Wright PS, Thomas SL Constipation and diarrhea: the neglected symptoms Semin Oncol Nurs 1995 Nov;11(4):289-97 Review PMID: 8578037

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Bethesda, Maryland 20892. Last update: 10/23/2004