None listed
Conditions
Brief summary
This study will investigate the effect of topical polaprezinc mouthwash on the incidence of oral mucositis in cancer patients undergoing haematopoietic stem cell transplantation Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with blood cancer and will receive high dose chemotherapy with or without total body irradiation (TBI) followed by autologous or allogeneic haematopoietic stem cell transplantation Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive polaprezinc mouthwash 4 times daily from hospital admission until neutrophil recovery (approximately 20 days). Participants in the other group will receive sodium bicarbonate mouthwash 4 times daily from hospital admission until neutrophil recovery (approximately 20 days). Daily oral assessment will be conducted by nurses and oral mucositis severity will be graded according to the WHO mucositis scale. Patients will be asked to complete an oral mucositis daily questionnaire that evaluates their oral pain and functional difficulties. Patients’ compliance, acceptability of the mouthwashes, total opioid and patient controlled analgesia (PCA) use, enteral nutrition (EN) and total parenteral nutrition (TPN) use will be collected. If polaprezinc lower the incidence and severity of oral mucositis, it may be used in the future as an effective, inexpensive and safe prevention of oral mucositis.
Interventions
Polaprezinc mouthwash will be compared to sodium bicarbonate mouthwash (standard of care) in addition to saline mouthwash.
Treatment arm: Saline 10mL followed by polaprezinc 5mL four times a day as mouthwash
The concentration of polaprezinc mouthwash: 75mg in 20mL water. Each dose will be provided in a single use syringe.
The treatent duration: from hospital admission to neutrophil recovery (approximately 14-21 days)
Patient will swirl polaprezinc in the mouth for 30 seconds then spit. Used mout
Polaprezinc mouthwash will be compared to sodium bicarbonate mouthwash (standard of care) in addition to saline mouthwash. Treatment arm: Saline 10mL followed by polaprezinc 5mL four times a day as mouthwash The concentration of polaprezinc mouthwash: 75mg in 20mL water. Each dose will be provided in a single use syringe. The treatent duration: from hospital admission to neutrophil recovery (approximately 14-21 days) Patient will swirl polaprezinc in the mouth for 30 seconds then spit. Used mouthwash syringes will be collected daily to assess adherence.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible patients are those who receive high dose chemotherapy with or without total body irradiation (TBI) followed by autologous or allogeneic HSCT. Patients receiving myeloablative regimens, fludarabine/melphalan, BEAM, high dose melphalan and other regimens with similar oral mucositis risks will be included.
Exclusion criteria
Patients who have oral mucositis prior to HSCT Patients with low risk of developing oral mucositis (e.g. CAR-T cells, Donor lymphocyte infusion) Patients who are planned to be transfer or discharge from the hospital before neutrophil recovery. Patients who require a translator
Outcome results
None listed