None listed
Conditions
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.
Interventions
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 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.
Sponsors
Amanda Christina C. Dujua, MD
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Healthy volunteers
No
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
Exclusion criteria
Children with oral mucositis or any oral lesion at initial assessment. Children with the following conditions: hypersensitivity to iodine, hyperthyroidism, mental retardation.
Outcome results
None listed