A randomised trial of polaprezinc mouthwash for oral mucositis in cancer patients undergoing stem cell transplantatio

Phase 2

Completed

• Conditions: oral mucositis; Blood cancer; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Cancer - Hodgkin's; Cancer - Leukaemia - Acute leukaemia; Cancer - Leukaemia - Chronic leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma; Cancer - Myeloma

• Registration Number: ACTRN12620001188921
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-10
• Study Completion: 2022-08-08
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified