Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy

NCT ID: NCT01661413

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-07
• Study Completion Date: 2015-10-31

Brief Summary

Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy. Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during treatment reported by paediatric cancer survivors. Complete prevention of both nausea and vomiting is the goal of anti-vomiting and nausea medications. It is important to understand whether or not certain chemotherapeutic treatments are more or less likely to cause these symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal methotrexate is an important part of chemotherapy for the prevention and treatment of central nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal methotrexate will cause nausea and vomiting will therefore be important to optimize treatment for these side-effects of chemotherapy. The primary aim of this prospective study is to evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric cancer patients.

Conditions

Acute Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute Leukemia

Children diagnosed with acute leukemia, undergoing chemotherapy. Patients with acute leukemia will receive intrathecal methotrexate on day 1 plus intravenous vincristine on day 1 plus oral steroid on days 1-5 plus their regularly scheduled and ongoing daily oral 6-mercaptopurine at the start of a maintenance therapy cycle.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 4 years old to 18 years of age (age range in which the PeNAT has been validated) [18]
• English speaking (PeNAT has been validated only in English)
• Cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional
• Patients are past their first cycle of maintenance therapy to avoid interactions with the intensive chemotherapy phase.

Exclusion Criteria

• Receiving chemotherapy other than dictated by protocol for maintenance therapy within 24 hours prior to or 24 hours following receipt of intrathecal methotrexate

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Angela Punnett

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Punnett, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Lee Dupuis, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000030743

Identifier Type: -

Identifier Source: org_study_id