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Curcumin for Prevention of Oral Mucositis in Children Chemotherapy

NCT00475683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-08-18

No results posted yet for this study

Summary

Mucositis consists of inflammation of the mucosal membrane and is a prominent cause of patient discomfort during cancer therapy. In children receiving chemotherapy, the incidence of oral mucositis is reported to be between 40%-70%. Curcumin, a commonly-used spice in India and Southeast Asia, was shown in animal models to prevent chemotherapy and radiotherapy induced mucositis. We hypothesize that curcumin may prevent oral mucosal injury and reduce the severity of oral mucositis in children receiving chemotherapy. Thus, the aim of this study is to determine whether in children undergoing doxorubicin-containing chemotherapy, does supplementation of curcumin, when compared to placebo, decrease oral mucositis both by objective (mucositis scales) and subjective (pain scale) measurements. Effective prevention and reduction of mucosal injury may significantly improve the care we provide to children undergoing therapy for cancer.

Conditions

  • Chemotherapy Induced Mucositis

Interventions

OTHER

Mouth wash

Mouth wash with chlorehexidin, three times a day

DIETARY_SUPPLEMENT

Curcumol

5 ml in 50 ml water, mouthwash for 30 seconds, three times a day

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Shoshana Revel-Vilk, MD · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00475683 on ClinicalTrials.gov