A Study for the role of acyclovir to prevent chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation

A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003885

Enrollment

Registered

2019-05-03

Start date

2019-06-24

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. Study group (Prophylaxis group) Patients recieve acyclovir from the start date of conditioning to the date of neutrophil engraftment. Acyclovir 400 mg bid (oral acyclovir can be changed into

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients over the age of 19 (2) Patients with lymphoma or multiple myeloma will receive autologous hematopoietic stem cell transplantation during the study period (3) Patients who HSV of serology IgM Negative and IgG Positive (4) Patients who voluntarily agrees and signs participation in the study

Exclusion criteria

Exclusion criteria: (1) Patients who experienced reactivation of HSV more than 2 times before (2) Patients who have oral ulcer or herpes simplex at the start date of autologous hematopoietic stem cell transplantation (3) Patients who have severe dental disease or poor dental hygeine at the start date of autologous hematopoietic stem cell transplantation and therefore not valid for the study (4) At the other autologous hematopoietic stem cell transplantation, patients who must use necessarily prophylaxis for anti-HSV or prohibition and therefore that it is not appropriate for randomization therapy to physician's determination (5) GFR less than 60 mL/min/1.73m2, calculated by MDRD (Modification of Diet in Renal Disease) (6) Pregnant or lactating women (7) Patients who have history of hypersensitivity for acyclovir or ingredients of acyclovir and valaciclovir (8) Patients who already detected HSV-1 in oral cavity at screening (9) Patient who received Day 3 and Day 2 based conditioning of high dose melphalan for multiple myeloma(Unlike Conditioning of lymphoma or multiple myeloma including busulfan, high dose melphalan is excluded due to timeline a difference of stomatitis and delayed 4 to 6 days at start date of conditioning)

Design outcomes

Primary

Measure	Time frame
cumulative incidence of chemotherapy-induced oral mucositis	—

Secondary

Measure	Time frame
severity and pain score of chemotherapy-induced oral mucositis;cumulative incidence of HSV reactivation;Incidence of adverse events according to acyclovir use	—

Countries

Korea, Republic of

Contacts

Public ContactJamin Byun

Seoul National University Hospital

jaminbyun@naver.com+82-2-2072-1477

Outcome results