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Curcumin for Prevention of Oral Mucositis in Children Chemotherapy

Primary Purpose

Chemotherapy Induced Mucositis

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Mouth wash
Curcumol
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy Induced Mucositis focused on measuring Doxorubicin, Mucositis, Prevention, Curcumin

Eligibility Criteria

5 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

regular measurments

Curucmol

Arm Description

Mouth wash with chlorexidin

mouth wash with curcumol and mouth wash with chlorexidin

Outcomes

Primary Outcome Measures

To determine whether in children undergoing doxorubicin-containing chemotherapy, does supplementation of curcumin, when compared to placebo, decrease an objective measurement of oral mucositis?

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2007
Last Updated
August 17, 2015
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00475683
Brief Title
Curcumin for Prevention of Oral Mucositis in Children Chemotherapy
Official Title
Randomized Cross-over Study of Curcumin for Prevention of Oral Mucositis in Children Receiving Doxorubicin Based Chemotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Mucositis
Keywords
Doxorubicin, Mucositis, Prevention, Curcumin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
regular measurments
Arm Type
Sham Comparator
Arm Description
Mouth wash with chlorexidin
Arm Title
Curucmol
Arm Type
Experimental
Arm Description
mouth wash with curcumol and mouth wash with chlorexidin
Intervention Type
Other
Intervention Name(s)
Mouth wash
Intervention Description
Mouth wash with chlorehexidin, three times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumol
Intervention Description
5 ml in 50 ml water, mouthwash for 30 seconds, three times a day
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, 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, Patient's/ parent's informed consent. Exclusion Criteria: Patients treated with antiplatelet therapy or anticoagulation, Patients with biliary tract obstruction, Patients with preexisting oral disease, such as active oral infection, trauma to the oral mucosa or oral ulceration prior to chemotherapy, Patients receiving head and neck radiation, Developmentally unable to comply with curcumin mouth wash as judged by the parent or investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shoshana Revel-Vilk, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Curcumin for Prevention of Oral Mucositis in Children Chemotherapy

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