Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000158662
Ethics application status
Approved
Date submitted
12/01/2014
Date registered
10/02/2014
Date last updated
10/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of oral mucositis in pediatric patients with acute lymphoblastic leukemia undergoing chemotherapy: a randomized controlled, cross-over trial using 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwash
Scientific title
Prevention of oral mucositis in pediatric patients with acute lymphoblastic leukemia undergoing chemotherapy: a randomized controlled, cross-over trial using 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwash
Secondary ID [1] 283894 0
NIL
Universal Trial Number (UTN)
U1111-1151-6914
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oral mucositis 290881 0
leukemia 290882 0
Condition category
Condition code
Cancer 291238 291238 0 0
Children's - Leukaemia & Lymphoma
Oral and Gastrointestinal 291454 291454 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two period cross-over trial. Intervention with mouth-rinsing will commence at the start of either induction, consolidation, or re-induction chemotherapy phase. Group 1 will be rinse with 10 mL of 0.12% chlorhexidine gluconate mouthwash twice daily, and Group 2 will rinse with 15 mL of 1% povidone iodine mouthwash twice daily, for 14 days during the first period of study. Alkaline saline mouthrinse will be used by the subjects during the 2 week ‘washout’ time between the two periods of study. The two groups will then switch mouthrinses during the second study period. The occurrence of ulcerative lesions and severity of mucositis will be measured at baseline and twice weekly of each study period, using the Oral Mucositis Assessment Scale and World Health Organization Grading Scale. If oral mucositis/ulceration develops during either period and persists beyond 14 days, the subjects will continue to use the mouthwash assigned to their group until lesions heal. A participant diary on the use of mouthwash and other oral care hygiene measures such as toothbrushing and flossing will be used to monitor adherence to treatment.
Intervention code [1] 288570 0
Prevention
Intervention code [2] 288708 0
Treatment: Drugs
Comparator / control treatment
0.12% chlorhexidine gluconate mouthwash and 1% povidone iodine mouthwash. The comparator is 0.12% chlorhexidine mouthwash
Control group
Active

Outcomes
Primary outcome [1] 291235 0
determining whether there is a difference in effect of 0.12% chlorhexidine and 1% povidone iodine mouthrinses that are both accepted as standard of care for oral mucositis in pediatric cancer patients using the Oral Mucositis Assessment Scale and World Health Organization Grading Scale
Timepoint [1] 291235 0
2 weeks
Secondary outcome [1] 306302 0
Decrease in severity of oral mucositis, using the Oral Mucositis Assessment Scale and World Health Organization Grading Scale
Timepoint [1] 306302 0
2 weeks

Eligibility
Key inclusion criteria
Children ages of 6 to 18 years old diagnosed with Acute Lymphoblastic Leukemia who are undergoing Induction, Consolidation, or Re-induction chemotherapy (based on the Modified Berlin-Frankfurt-Munster Acute Lymphoblastic Leukemia Protocol) or Induction or Intensification chemotherapy (based on the Children’s Cancer Group Protocol, CCG-1941: Bone Marrow Transplantation versus Prolonged Intensive Chemotherapy for Children with Acute Lymphoblastic Leukemia after an Initial Bone Marrow Relapse) and seeking consult at STUH-BCI, and are capable of tooth-brushing and mouth-rinsing as judged by the principal investigator
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with oral mucositis or any oral lesion at initial assessment.
Children with the following conditions: hypersensitivity to iodine, hyperthyroidism, mental retardation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomized (computer generated using Microsoft Excel software). Allocation was concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized (computer generated using Microsoft Excel software)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics are generated for all variables. Descriptive measures include: Percentage, Mean, Standard deviation. For nominal data, frequencies and percentages are computed. For numerical data, mean +/- SD were generated. Two-way ANOVA, Mc Nemar, and Chi square test are used for test of significance. The 0.05 levels is used as the cut off values for statistical significance (p =0.05). The results are demonstrated as tables and graphs.This research is limited to the study of a subset population of pediatric acute lymphoblastic leukemia ages 6 to 18 years old. Sample size is determined statistically using the effect size based on the results of the study “Comparison effects of chlorhexidine gluconate and povodine iodine mouthwashes to chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia” by Setiawan et al. done in 2006 (as cited in the review of literature) which showed that the mucositis and its related pain healed in mean of 6.1 days (range of 5 to 7) for the chlorhexidine group and mean of 11 days (range of 8 to 14) for the povidone iodine group. To detect an effect size of 1.231, under alpha error of 0.05 and power of 0.80, at least nine subjects will be used in the study. Calculation is performed using PASS 11 for Windows. (Hintze, J. PASS 11, NCSS, LLF, 2011. www.ncss.com)

A sample size of 9 achieves 85% power to detect a mean of paired differences of 4.8 of an estimated standard deviation of differences of 3.9 and with a significance level (alpha) of 0.05000 using a two-sided Wilcoxon test assuming that the actual distribution is normal.
This research study will use a sample size of 20 for better statistical outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/08/2013
Actual
18/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5745 0
Philippines
State/province [1] 5745 0

Funding & Sponsors
Funding source category [1] 288535 0
Self funded/Unfunded
Name [1] 288535 0
Amanda Christina C. Dujua, MD
Country [1] 288535 0
Philippines
Primary sponsor type
Individual
Name
Amanda Christina C. Dujua, MD
Address
Department of Pediatrics
University of Santo Tomas
Espana Boulevard
Sampaloc, Manila 1005
Country
Philippines
Secondary sponsor category [1] 287247 0
Individual
Name [1] 287247 0
Flerida G. Hernandez, MD
Address [1] 287247 0
Department of Pediatrics
University of Santo Tomas
Espana Boulevard
Sampaloc, Manila 1005
Country [1] 287247 0
Philippines

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290403 0
Santo Tomas University Hospital, Institutional Review Board and Ethics Research Committee
Ethics committee address [1] 290403 0
Espana Boulevard
Sampaloc, Manila 1005
Ethics committee country [1] 290403 0
Philippines
Date submitted for ethics approval [1] 290403 0
Approval date [1] 290403 0
15/08/2013
Ethics approval number [1] 290403 0

Summary
Brief summary
One of the most debilitating complications of chemotherapy is oral stomatositis. It occurs in up to 52-80% of children undergoing chemotherapy, and can start from the 3rd to 5th day after initiation of chemotherapy and lasts about 3 weeks. Standard oral hygiene includes several mouthwashes that may be chosen for prophylactic and therapeutic use, however, there are only a few studies which compare their efficacy in pediatric acute lymphoblastic leukemia. A consensus protocol regarding prophylaxis and treatment of oral mucositis is needed for this population of patients. General Objectives- To compare the efficacy of 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwash in the prevention of oral lesions in acute lymphoblastic leukemic children receiving chemotherapy. Specific Objectives- 1. To determine the demographic and clinical data of the participants as to: a) sex b) age c) type of leukemia d) phase of chemotherapy 2. To determine the effect of 0.12% chlorhexidine gluconate mouthwash and 1% povidone iodine mouthwash in the prevention and treatment of oral lesions in acute lymphoblastic leukemic children receiving chemotherapy as to: a) incidence b) severity of oral lesions c) duration of symptoms 3. To determine any side effects of 0.12% chlorhexidine gluconate mouthwash and 1% povidone iodine mouthwash
Methodology: Prospective, randomized controlled, non-blinded, two period cross-over trial. The study will be conducted at the Santo Tomas University Hospital and Benavides Cancer Institute (STUH-BCI). Twenty eligible children ages 6 to 18 years old diagnosed with Acute Lymphoblastic Leukemia who are undergoing chemotherapy will be divided into two groups. Group 1 will be rinse with 10 mL of 0.12% chlorhexidine gluconate mouthwash twice daily, and Group 2 will rinse with 15 mL of 1% povidone iodine mouthwash twice daily, for 14 days during the first period of study. Alkaline saline mouthrinse will be used by the subjects during the 2 week ‘washout’ time between the two periods of study. The two groups will then switch mouthrinses during the second study period. The occurrence of ulcerative lesions and severity of mucositis will be measured at baseline and twice weekly of each study period, using the Oral Mucositis Assessment Scale and World Health Organization Grading Scale. If oral mucositis/ulceration develops during either period and persists beyond 14 days, the subjects will continue to use the mouthwash assigned to their group until lesions heal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45490 0
Dr Amanda Christina C. Dujua
Address 45490 0
University of Santo Tomas
Department of Pediatrics
Espana Boulevard
Sampaloc, Manila 1005
Country 45490 0
Philippines
Phone 45490 0
+639258191978
Fax 45490 0
Email 45490 0
[email protected]
Contact person for public queries
Name 45491 0
Dr Amanda Christina C. Dujua
Address 45491 0
University of Santo Tomas
Department of Pediatrics
Espana Boulevard
Sampaloc, Manila 1005
Country 45491 0
Philippines
Phone 45491 0
+639258191978
Fax 45491 0
Email 45491 0
[email protected]
Contact person for scientific queries
Name 45492 0
Dr Amanda Christina C. Dujua
Address 45492 0
University of Santo Tomas
Department of Pediatrics
Espana Boulevard
Sampaloc, Manila 1005
Country 45492 0
Philippines
Phone 45492 0
+639258191978
Fax 45492 0
Email 45492 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.