Curcumin for Prevention of Oral Mucositis in Children Chemotherapy

NCT00475683 | Completed Phase 3 DMC

• 1 other identifier: Curcumin-HMO-CTIL
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy Induced Mucositis

Keywords

Doxorubicin; Mucositis; Prevention; Curcumin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

regular measurments

SHAM COMPARATOR

Mouth wash with chlorexidin

Other: Mouth wash

Curucmol

EXPERIMENTAL

mouth wash with curcumol and mouth wash with chlorexidin

Dietary Supplement: Curcumol

Interventions

Mouth wash OTHER

Mouth wash with chlorehexidin, three times a day

regular measurments

Curcumol DIETARY_SUPPLEMENT

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

Curucmol

Eligibility Criteria

• Age: 5 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Mucositis

Interventions

Mouthwashes; curcumol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Shoshana Revel-Vilk, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Shoshana Revel-Villk

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 18, 2015

Record last verified: 2011-06

Locations

IL (1)