A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation
Abstract Objectives To prove our hypothesis that acyclovir prophylaxis in autologous hematopoietic stem cell transplantation (AHSCT) recipients with hematologic malignancies (HM) reduces the incidence of chemotherapy-induced oral mucositis (CIOM) by inhibiting the intraoral HSV reactivation during t...
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| Format: | Article |
| Language: | English |
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BMC
2023-12-01
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| Series: | BMC Oral Health |
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| Online Access: | https://doi.org/10.1186/s12903-023-03623-6 |
| _version_ | 1797388050630705152 |
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| author | Junshik Hong Hee-Kyung Park Sung-Ho Chang Ja Min Byun Dong-Yeop Shin Youngil Koh Sung-Soo Yoon Youngnim Choi Inho Kim |
| author_facet | Junshik Hong Hee-Kyung Park Sung-Ho Chang Ja Min Byun Dong-Yeop Shin Youngil Koh Sung-Soo Yoon Youngnim Choi Inho Kim |
| author_sort | Junshik Hong |
| collection | DOAJ |
| description | Abstract Objectives To prove our hypothesis that acyclovir prophylaxis in autologous hematopoietic stem cell transplantation (AHSCT) recipients with hematologic malignancies (HM) reduces the incidence of chemotherapy-induced oral mucositis (CIOM) by inhibiting the intraoral HSV reactivation during the neutropenic period, we conducted a randomized phase II study of acyclovir for the prevention of CIOM in adult HSV sero-positive AHSCT recipients. Methods Patients were randomized to either the study group (acyclovir 400 mg PO bid until neutrophil engraftment) or the control group (no prophylaxis) and received AHSCT. Oral examination and sampling for HSV were performed at three timepoints of AHSCT. Results In 54 patients who were randomized (for intention-to-analysis), the incidence of CIOM was 16.0% (4/25 patients) and 58.6% (17/29 patients) in the study group and the control group, respectively (P = 0.001). In 49 patients who completed the study (for per-protocol analysis), the incidence of CIOM was 13.0% (3/23 patients) and 61.5% (16/26 patients) in the study group and the control group, respectively (P = 0.001). In addition, HSV-1 PCR positivity in the study group was significantly lower than that the control group (4.3% vs. 46.2%, P = 0.001). A strong association between the HSV-1 reactivation status and CIOM was reconfirmed. Conclusions Prophylactic use of oral acyclovir effectively reduced the incidence of CIOM in patients with HM who were undergoing AHSCT. Trial registrations This trial was registered at the Clinical Research Information Service in the Republic of Korea under the number KCT0003885 (registration date 03/05/2019). |
| first_indexed | 2024-03-08T22:34:08Z |
| format | Article |
| id | doaj.art-31b8c295a3d14ec8ae93ff6221375dd5 |
| institution | Directory Open Access Journal |
| issn | 1472-6831 |
| language | English |
| last_indexed | 2024-03-08T22:34:08Z |
| publishDate | 2023-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Oral Health |
| spelling | doaj.art-31b8c295a3d14ec8ae93ff6221375dd52023-12-17T12:32:01ZengBMCBMC Oral Health1472-68312023-12-012311710.1186/s12903-023-03623-6A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantationJunshik Hong0Hee-Kyung Park1Sung-Ho Chang2Ja Min Byun3Dong-Yeop Shin4Youngil Koh5Sung-Soo Yoon6Youngnim Choi7Inho Kim8Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Oral Medicine and Oral Diagnosis, Seoul National University Dental Hospital, Seoul National University School of DentistryDepartment of Immunology and Molecular Microbiology, School of Dentistry and Dental Research Institute, Seoul National UniversityDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of MedicineDepartment of Immunology and Molecular Microbiology, School of Dentistry and Dental Research Institute, Seoul National UniversityDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of MedicineAbstract Objectives To prove our hypothesis that acyclovir prophylaxis in autologous hematopoietic stem cell transplantation (AHSCT) recipients with hematologic malignancies (HM) reduces the incidence of chemotherapy-induced oral mucositis (CIOM) by inhibiting the intraoral HSV reactivation during the neutropenic period, we conducted a randomized phase II study of acyclovir for the prevention of CIOM in adult HSV sero-positive AHSCT recipients. Methods Patients were randomized to either the study group (acyclovir 400 mg PO bid until neutrophil engraftment) or the control group (no prophylaxis) and received AHSCT. Oral examination and sampling for HSV were performed at three timepoints of AHSCT. Results In 54 patients who were randomized (for intention-to-analysis), the incidence of CIOM was 16.0% (4/25 patients) and 58.6% (17/29 patients) in the study group and the control group, respectively (P = 0.001). In 49 patients who completed the study (for per-protocol analysis), the incidence of CIOM was 13.0% (3/23 patients) and 61.5% (16/26 patients) in the study group and the control group, respectively (P = 0.001). In addition, HSV-1 PCR positivity in the study group was significantly lower than that the control group (4.3% vs. 46.2%, P = 0.001). A strong association between the HSV-1 reactivation status and CIOM was reconfirmed. Conclusions Prophylactic use of oral acyclovir effectively reduced the incidence of CIOM in patients with HM who were undergoing AHSCT. Trial registrations This trial was registered at the Clinical Research Information Service in the Republic of Korea under the number KCT0003885 (registration date 03/05/2019).https://doi.org/10.1186/s12903-023-03623-6Oral mucositisHerpes simplex virusAutologous stem cell transplantationAcyclovirChemotherapy |
| spellingShingle | Junshik Hong Hee-Kyung Park Sung-Ho Chang Ja Min Byun Dong-Yeop Shin Youngil Koh Sung-Soo Yoon Youngnim Choi Inho Kim A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation BMC Oral Health Oral mucositis Herpes simplex virus Autologous stem cell transplantation Acyclovir Chemotherapy |
| title | A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation |
| title_full | A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation |
| title_fullStr | A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation |
| title_full_unstemmed | A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation |
| title_short | A randomized phase II study of acyclovir for the prevention of chemotherapy-induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation |
| title_sort | randomized phase ii study of acyclovir for the prevention of chemotherapy induced oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation |
| topic | Oral mucositis Herpes simplex virus Autologous stem cell transplantation Acyclovir Chemotherapy |
| url | https://doi.org/10.1186/s12903-023-03623-6 |
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