Status:

COMPLETED

Vitamin E to Prevent Mucositis in Children With Cancer

Lead Sponsor:

The Hospital for Sick Children

Conditions:

Cancer

Eligibility:

All Genders

6-18 years

Phase:

PHASE2

PHASE3

Brief 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 muc...

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 pai...

Eligibility Criteria

Inclusion

  • 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

  • allergy to vitamin E or placebo ingredients
  • child is unable to comply with topical vitamin E application
  • cild is receiving head or neck irradiation

Key Trial Info

Start Date :

July 1 2002

Trial Type :

INTERVENTIONAL

End Date :

February 1 2005

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT00311116

Start Date

July 1 2002

End Date

February 1 2005

Last Update

December 18 2013

Active Locations (1)

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1

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8