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Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy

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ClinicalTrials.gov Identifier: NCT01661413
Recruitment Status : Unknown
Verified July 2013 by Angela Punnett, The Hospital for Sick Children.
Recruitment status was:  Recruiting
First Posted : August 9, 2012
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Angela Punnett, The Hospital for Sick Children

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.

Condition or disease
Acute Leukemia

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine
Study Start Date : July 2012
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Acute Chemotherapy-Induced Nausea and Vomiting [ Time Frame: Over 24 hours after receiving intrathecal methotrexate on day 1 ]
    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.


Secondary Outcome Measures :
  1. Anticipatory Chemotherapy-Induced Nausea and Vomiting [ Time Frame: Baseline ]
    To describe the prevalence of anticipatory nausea and vomiting in these patients. Anticipatorty nausea and vomiting begins prior to the administration of chemotherapy in patients who have previously received chemotherapy.

  2. Delayed Chemotherapy-Induced Nausea and Vomiting [ Time Frame: Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate ]
    To describe the prevalence of delayed phase CINV in these patients. Delayed CINV develops after the initial 24 hours and might last up to 7 days.



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661413


Contacts
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Contact: Angela Punnett, MD (416)813-7703 angela.punnett@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Angela Punnett, MD    (416)813-7703    angela.punnett@sickkids.ca   
Principal Investigator: Angela Punnett, MD         
Principal Investigator: Lee Dupuis, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Angela Punnett, MD The Hospital for Sick Children
Principal Investigator: Lee Dupuis, MD The Hospital for Sick Children

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Responsible Party: Angela Punnett, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01661413     History of Changes
Other Study ID Numbers: 1000030743
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013
Keywords provided by Angela Punnett, The Hospital for Sick Children:
Acute Leukemia
Pediatrics
Intrathecal methotrexate
Chemotherapy
Nausea
Vomiting
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Methotrexate
Vincristine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators