NCT00475683|CompletedPhase 3DMC
Curcumin for Prevention of Oral Mucositis in Children Chemotherapy
Randomized Cross-over Study of Curcumin for Prevention of Oral Mucositis in Children Receiving Doxorubicin Based Chemotherapy.
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Sponsor study identifier
interventional
8
1 country
1
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2007
Actual (reported)May 21, 2007
Actual (reported)January 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 2010
Actual (reported)December 2010
Actual (reported)To determine whether in children undergoing doxorubicin-containing chemotherapy, does supplementation of curcumin, when compared to placebo, decrease an objective measurement of oral mucositis?
6 weeks
To determine whether in children undergoing doxorubicin-containing chemotherapy, does supplementation of curcumin, when compared to placebo, decrease mucositis related pain, use of opioids and parenteral nutrition.
6 weeks
Mouth wash with chlorexidin
mouth wash with curcumol and mouth wash with chlorexidin
Mouth wash with chlorehexidin, three times a day
5 ml in 50 ml water, mouthwash for 30 seconds, three times a day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hadassah Medical Organization
Jerusalem, Israel
Shoshana Revel-Vilk, MD
Hadassah Medical Organization
8 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2007
First Posted
May 21, 2007
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
August 18, 2015
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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