None listed
Conditions
Brief summary
This study aimed to investigate the safety and efficacy of coconut oil mouthwash in preventing and treating oral mucositis in children receiving cancer treatment. This study has completed recruitment. Who is it for? Participants in this study were aged 6 – 16 years, were receiving treatment for cancer and undergoing a chemotherapy cycle expected to result in a neutrophil count of <0.5x10^9/L. Study details Participants were randomly allocated (by chance) to one of two groups: one group used chlorhexidine 0.2% mouthwash, four times daily, over the course of one cycle of chemotherapy. The other group used virgin coconut oil mouthwash twice daily, in addition to four daily mouthwashes using chlorhexidine 0.2% mouthwash. Both groups completed a daily e-Diary for the duration of the cycle of chemotherapy. Both groups had mouth swabs taken before, during and after the chemotherapy cycle. It is hoped that this research will determine whether coconut oil mouthwash is a safe and effective prevention and treatment for oral mucositis in children receiving cancer treatment.
Interventions
Participants randomized 1:1 to receive either routine chlorhexidine 0.2% 5ml mouthwash four times daily (control) or chlorhexidine plus two additional virgin coconut oil 5ml mouthwashes daily (intervention) during one cycle of chemotherapy. Safety, feasibility, compliance and episodes of oral mucositis are assessed using daily e-Diary, to be completed by the parent. Oral microbial swabs are collected for qualitative and quantitative microbial profiling at three timepoints during the study; basel
Participants randomized 1:1 to receive either routine chlorhexidine 0.2% 5ml mouthwash four times daily (control) or chlorhexidine plus two additional virgin coconut oil 5ml mouthwashes daily (intervention) during one cycle of chemotherapy. Safety, feasibility, compliance and episodes of oral mucositis are assessed using daily e-Diary, to be completed by the parent. Oral microbial swabs are collected for qualitative and quantitative microbial profiling at three timepoints during the study; baseline, one week into chemotherapy cycle and one week after completion of chemotherapy cycle. Chemotherapy cycle duration varies depending on condition and treatment protocol, however average 28 days (range 3-8 weeks).
Sponsors
Child and Adolescent Health Service Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 6-16 years, receiving treatment for an oncological condition, free of severe infection, and undergoing a chemotherapy cycle expected to result in a neutrophil count of <0.5x109/L, when mucositis is more likely to occur
Exclusion criteria
Non-compliance risk, allogeneic transplant or autologous stem cell rescue, maintenance therapy for acute lymphoblastic leukemia, and known allergies to coconut oil
Outcome results
None listed