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Curcumin for Prevention of Oral Mucositis in Children Chemotherapy

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ClinicalTrials.gov Identifier: NCT00475683
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Shoshana Vilk, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE May 17, 2007
First Posted Date  ICMJE May 21, 2007
Last Update Posted Date August 18, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2007)
To determine whether in children undergoing doxorubicin-containing chemotherapy, does supplementation of curcumin, when compared to placebo, decrease an objective measurement of oral mucositis? [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00475683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2007)
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. [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin for Prevention of Oral Mucositis in Children Chemotherapy
Official Title  ICMJE Randomized Cross-over Study of Curcumin for Prevention of Oral Mucositis in Children Receiving Doxorubicin Based Chemotherapy.
Brief 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.
Detailed Description Children older than 5 years of age diagnosed with cancer and treated at the Pediatric Hematology/Oncology unit, Hadassah Medical Center will be eligible to the study. The study is designed as a cross-over study, wherein each patient serves as his or her own control, thus all included children should be scheduled to receive at least two identical curses of doxorubicin-containing chemotherapy in which the dose of doxorubicin is at least 60mg/m2 per course. The patients will be assigned to randomly receive curcumin or placebo in the 1st course, with the other regimen administered at the 2nd course. Curcumin will be given as fluid extract (1:1) at a dose of 10 drops, three times a day. Adolescents and young adults will receive the adult recommend dose, i.e. 30 drops, three times a day. Placebo will be given at the same dose. The patients will be taught to rinse the mouth with the medicine and than spit out. The therapy will be given from a day prior to the first day of the cycle for two weeks. A diary kept by the family will record each given dose. Possible side effects associated with the study drug, such as vomiting, nausea, rash, etc., will be recorded. No other adjunctive topical treatment will be used during the study. Adherence will be assessed through subject reports as well as by review of returned medications every cycle collected during the objective assessment site visits. Given the intent-to-treat analysis, all participants will be included irrespective of how much of the study medication was taken.The measurements of study outcome, i.e. OMAS score, WHO mucositis scale and visual analogue pain scale will be done on day 1,7,10,14,21 ± 1 of each chemotherapy cycle. The following data will be recorded in all cycles: duration of neutropenia, the need and length of hospitalization, use and dosage of opioid analgesia, need for total potential nutrition, blood culture positive infection and other mucositis related complications.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy Induced Mucositis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Sham Comparator: regular measurments
    Mouth wash with chlorexidin
    Intervention: Other: Mouth wash
  • Experimental: Curucmol
    mouth wash with curcumol and mouth wash with chlorexidin
    Intervention: Dietary Supplement: Curcumol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2015)
8
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Children older than 5 years of age, adolescents and young adults diagnosed with cancer and treated at the Pediatric Hematology/Oncology unit, Hadassah Medical Center,
  2. A crossover study design is planed wherein each patient serves as his or her own control, thus all included children should be scheduled to receive at least two identical curses of doxorubicin-containing chemotherapy in which the dose of doxorubicin is at least 60mg/m2 per course,
  3. Patient's/ parent's informed consent.

Exclusion Criteria:

  1. Patients treated with antiplatelet therapy or anticoagulation,
  2. Patients with biliary tract obstruction,
  3. Patients with preexisting oral disease, such as active oral infection, trauma to the oral mucosa or oral ulceration prior to chemotherapy,
  4. Patients receiving head and neck radiation,
  5. Developmentally unable to comply with curcumin mouth wash as judged by the parent or investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00475683
Other Study ID Numbers  ICMJE Curcumin-HMO-CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shoshana Vilk, Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shoshana Revel-Vilk, MD Hadassah Medical Center
PRS Account Hadassah Medical Organization
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP