CancerPhase 2/3NCT00311116
Vitamin E to Prevent Mucositis in Children With Cancer
A Phase 2/3 study testing Vitamin E in people with Cancer, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The primary objective is to determine whether in children undergoing doxorubicin-containing chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective measurement of oral mucositis. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Vitamin E
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2002to Feb 2005
- Phase
- Phase 2/3
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of cancer and treated at the Hospital for Sick Children, Toronto, Canada
- planned chemotherapy includes at least two identical courses of doxorubicin-containing chemotherapy in which the dose of doxorubicin was at least 60 mg/m2 per course
- at least 6 years of age and less than 18 years
- lives in the Greater Toronto area
Who cannot join
- allergy to vitamin E or placebo ingredients
- child is unable to comply with topical vitamin E application
- cild is receiving head or neck irradiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial Controlled N-of-1 Trials of Topical Vitamin E as Prophylaxis for Chemotherapy-induced Oral Mucositis in Pediatric Patients
The primary objective is to determine whether in children undergoing doxorubicin-containing chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective measurement of oral mucositis.
Read the detailed description
Oral mucositis is a common consequence of chemotherapy and is an important sequela of cancer therapy because it is painful and affects quality of life, may lead to hospitalization for hydration or pain control, and provides a portal of entry for oral microflora. In addition, oral mucositis has become a major dose-limiting toxicity and consequently, may limit delivery of anti-cancer therapy.
Despite the frequency of mucositis, there are no feasible therapies proven to be successful in preventing mucositis in children. Vitamin E is a fat-soluble essential vitamin that may protect against doxorubicin-induced oral mucositis through its anti-oxidant properties.
In this study, we will examine the efficacy of topical vitamin E as prophylaxis against chemotherapy-induced mucositis with a novel methodology appropriate for the study of rare conditions, namely combining N-of-1 trials using Bayesian meta-analysis.
The primary outcome is an objective mucositis score measured on days 7, 10, 14 and 17. Secondary outcomes included daily pain and swallowing visual analogue scale scores, and World Health Organization mucositis scores collected on days 5 to 20.
Comparisons: Objective and subjective mucositis scores will be compared in cycles associated with topical vitamin E versus cycles associated with placebo administration. We will use repeated measures analysis within a Bayesian framework in order to conduct this comparison.
- Conditions
- Cancer
- Being tested
- Vitamin E
- Keywords
- Vitamin E, Cancer, pediatrics, supportive care, oral mucositis, Bayesian analysis, N-of-1 trial, prophylaxis
- Medical subject headings
- Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy
Secondary outcomes (6)
Pain visual analogue scale
Difficulty swallowing visual analogue scale
World Health Organization mucositis grade
Analgesia use (topical, systemic non-narcotic or narcotic
Receipt of intravenous fluid, and total parenteral nutrition.
Chemotherapy decrements or delays due to mucositis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startJul 2002
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Feldman, The Hospital for Sick Children
- Investigators
- Brian M Feldman, MD, MSc, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311116
- Sponsor's protocol ID
- 0020010130
- Status last verified
- Dec 2013
- First submitted
- 3 Apr 2006
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Controlled N-of-1 Trials of Topical Vitamin E as Prophylaxis for Chemotherapy-induced Oral Mucositis in Pediatric Patients
- ClinicalTrials.gov ID
- NCT00311116
- Acronym / sponsor ID
- 0020010130
- Conditions
- Cancer
- Keywords
- Vitamin E, Cancer, pediatrics, supportive care, oral mucositis, Bayesian analysis, N-of-1 trial, prophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- Feb 2005
- First posted
- 5 Apr 2006 (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.
The primary objective is to determine whether in children undergoing doxorubicin-containing chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective measurement of oral mucositis.
Detailed description
Oral mucositis is a common consequence of chemotherapy and is an important sequela of cancer therapy because it is painful and affects quality of life, may lead to hospitalization for hydration or pain control, and provides a portal of entry for oral microflora. In addition, oral mucositis has become a major dose-limiting toxicity and consequently, may limit delivery of anti-cancer therapy.
Despite the frequency of mucositis, there are no feasible therapies proven to be successful in preventing mucositis in children. Vitamin E is a fat-soluble essential vitamin that may protect against doxorubicin-induced oral mucositis through its anti-oxidant properties.
In this study, we will examine the efficacy of topical vitamin E as prophylaxis against chemotherapy-induced mucositis with a novel methodology appropriate for the study of rare conditions, namely combining N-of-1 trials using Bayesian meta-analysis.
The primary outcome is an objective mucositis score measured on days 7, 10, 14 and 17. Secondary outcomes included daily pain and swallowing visual analogue scale scores, and World Health Organization mucositis scores collected on days 5 to 20.
Comparisons: Objective and subjective mucositis scores will be compared in cycles associated with topical vitamin E versus cycles associated with placebo administration. We will use repeated measures analysis within a Bayesian framework in order to conduct this comparison.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- diagnosis of cancer and treated at the Hospital for Sick Children, Toronto, Canada
- planned chemotherapy includes at least two identical courses of doxorubicin-containing chemotherapy in which the dose of doxorubicin was at least 60 mg/m2 per course
- at least 6 years of age and less than 18 years
- lives in the Greater Toronto area
Key exclusion criteria (3 listed)
- allergy to vitamin E or placebo ingredients
- child is unable to comply with topical vitamin E application
- cild is receiving head or neck irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E | Drug | – |
Primary outcome
Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy
6 secondary outcomes
Pain visual analogue scale
Difficulty swallowing visual analogue scale
World Health Organization mucositis grade
Analgesia use (topical, systemic non-narcotic or narcotic
Receipt of intravenous fluid, and total parenteral nutrition.
Chemotherapy decrements or delays due to mucositis
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 Dec 2013.
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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.
Brian M Feldman, MD, MSc 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?
A Phase 2/3 study testing Vitamin E in people with Cancer, 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 3 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 Dec 2013. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy. 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 Dec 2013.