Clinical trial · Interventional
Vitamin E to Prevent Mucositis in Children With Cancer
Serial Controlled N-of-1 Trials of Topical Vitamin E as Prophylaxis for Chemotherapy-induced Oral Mucositis in Pediatric Patients
NCT00311116CI-TRIAL-00013077completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin E | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy
Secondary outcomes (6)
- measure
- Pain visual analogue scale
- measure
- Difficulty swallowing visual analogue scale
- measure
- World Health Organization mucositis grade
- measure
- Analgesia use (topical, systemic non-narcotic or narcotic
- measure
- Receipt of intravenous fluid, and total parenteral nutrition.
- measure
- Chemotherapy decrements or delays due to mucositis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * allergy to vitamin E or placebo ingredients * child is unable to comply with topical vitamin E application * cild is receiving head or neck irradiation
References
Publications (0)
Data not yet available
No reference posted for this study.