Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy

NCT01661413 | Completed

• 1 other identifier: 1000030743
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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

Keywords

Acute Leukemia; Pediatrics; Intrathecal methotrexate; Chemotherapy; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• Acute Chemotherapy-Induced Nausea and Vomiting

  To describe the prevalence of acute phase CINV in these patients. Acute CINV is defined as nausea, vomiting or retching occurring within the first 24 hours following chemotherapy.

  Over 24 hours after receiving intrathecal methotrexate on day 1

Secondary Outcomes (2)

• Anticipatory Chemotherapy-Induced Nausea and Vomiting

  Baseline

• Delayed Chemotherapy-Induced Nausea and Vomiting

  Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate

Study Arms (1)

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.

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Receiving intrathecal methotrexate in the context of maintenance therapy for acute lymphoblastic leukemia and as dosed by age per protocol. Patients will also receive their protocol driven maintenance chemotherapy which includes oral 6 mercaptopurine and may include IV vincristine and an oral steroid pulse (prednisone or dexamethasone). Oral methotrexate is typically held the weeks that patients receive intrathecal methotrexate during maintenance therapy.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

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

Study Officials

• Angela Punnett, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Lee Dupuis, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 9, 2012
• Study Start: May 7, 2012
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

CA (1)