Acute LeukemiaNCT01661413
Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy
An observational study of Acute Leukemia, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Acute Leukemia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2012to 31 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Receiving chemotherapy other than dictated by protocol for maintenance therapy within 24 hours prior to or 24 hours following receipt of intrathecal methotrexate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine
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
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over 24 hours after receiving intrathecal methotrexate on day 1
Secondary outcomes (2)
Anticipatory Chemotherapy-Induced Nausea and Vomiting
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.
Measured: Baseline
Delayed Chemotherapy-Induced Nausea and Vomiting
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.
Measured: Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study start7 May 2012
- Primary completion31 Oct 2015
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Punnett, The Hospital for Sick Children
- Investigators
- Angela Punnett, MD, Principal investigator, The Hospital for Sick ChildrenLee Dupuis, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661413
- Sponsor's protocol ID
- 1000030743
- Status last verified
- Nov 2019
- First submitted
- 7 Aug 2012
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine
- ClinicalTrials.gov ID
- NCT01661413
- Acronym / sponsor ID
- 1000030743
- Conditions
- Acute Leukemia
- Keywords
- Acute Leukemia, Pediatrics, Intrathecal methotrexate, Chemotherapy, Nausea, Vomiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 7 May 2012 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Receiving chemotherapy other than dictated by protocol for maintenance therapy within 24 hours prior to or 24 hours following receipt of intrathecal methotrexate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Anticipatory Chemotherapy-Induced Nausea and Vomiting
Time frame: Baseline
Delayed Chemotherapy-Induced Nausea and Vomiting
Time frame: Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Punnett, MD principal investigator
The Hospital for Sick Children
Lee Dupuis, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Chemotherapy-Induced Nausea and Vomiting (time frame: Over 24 hours after receiving intrathecal methotrexate on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.