Randomized Cross-over Study of Curcumin for Prevention of Oral Mucositis in Children Receiving Doxorubicin Based Chemotherapy.
5 Years
30 Years
Both
Chemotherapy Induced Mucositis
Trial Information
Randomized Cross-over Study of Curcumin for Prevention of Oral Mucositis in Children Receiving Doxorubicin Based Chemotherapy.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
To determine whether in children undergoing doxorubicin-containing chemotherapy, does supplementation of curcumin, when compared to placebo, decrease an objective measurement of oral mucositis?
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Shoshana Revel-Vilk, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hadassah Medical Center
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
Curcumin-HMO-CTIL
NCT ID:
NCT00475683
Start Date:
January 2009
Completion Date:
December 2010
Related Keywords:
- Chemotherapy Induced Mucositis
- Doxorubicin
- Mucositis
- Prevention
- Curcumin
- Stomatitis
- Mucositis
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