Trial Information

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

Children with cancer are treated with complex therapies including chemotherapy, radiation,
surgical interventions and biotherapy. Treatment with vinca alkaloids and/or narcotics
combined with significant lifestyle changes secondary to the disease process can have a
negative impact on the child's bowel elimination status. In trying to preserve the child's
health and well being, constipation can be minimized or even prevented as an unwanted side
effect of the treatments or disease condition.

Despite the widespread knowledge that constipation is prevalent in oncology patients,
evidence shows that cancer treatment plans often overlook constipation and reflect the lack
of consensus for effective assessment, treatment, and management. The research literature
provides a database for addressing particular aspects of constipation. However, few studies
address all the factors that affect bowel function and fewer still have recruited pediatric
populations.

The Constipation Assessment Scale (CAS) is a valid and reliable measure found to be
predictive of the presence and severity of constipation in the adult population, however it
has never been tested in the pediatric population. A pilot study utilizing the CAS tool in
children diagnosed with cancer will be conducted. The process for evaluating the presence
and severity of constipation and the reliability and validity of the CAS tool will be
tested. The study population will consist of inpatients and outpatients less than or equal
to 21 years old, receiving weekly vinca alkaloids and/or narcotics greater than or equal to
2 times per day for pain management. Patients will be followed for 7 days after the last
dose of vinca alkaloid and/or narcotic for a maximum of 6 weeks. Patients will be assessed
on admission for bowel function and constipation. The admission assessment will include a
nursing and nutrition assessment, review of the history and physical, and the administration
of the CAS. Subsequent assessments include nursing, nutrition, administration of the CAS,
and a patient daily bowel diary.

All patients regardless of participation in the study will be prescribed interventions based
on the bowel prophylaxis and management guidelines established by the NCI POB staff. These
guidelines were generated from validated studies, using Medline's criteria for scientific
soundness and clinical relevance, in the oncology literature as well as from the experience
of the NCI POB staff.