Curcumin for Prevention of Oral Mucositis in Children Chemotherapy

NCT ID: NCT00475683

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

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.

Conditions

Chemotherapy Induced Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

regular measurments

Mouth wash with chlorexidin

Group Type: SHAM_COMPARATOR

Mouth wash

Intervention Type: OTHER

Mouth wash with chlorehexidin, three times a day

Curucmol

mouth wash with curcumol and mouth wash with chlorexidin

Group Type: EXPERIMENTAL

Curcumol

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Mouth wash

Mouth wash with chlorehexidin, three times a day

Intervention Type: OTHER

Curcumol

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Shoshana Vilk

Prof. Shoshana Revel-Villk

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shoshana Revel-Vilk, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

Curcumin-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id