Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

Official title

Clinical Study of Moxibustion for the Prevention of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation

Overview

This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.

Interventions

• Other Moxibustion
  The experimental group received moxibustion of Zhongji, Guanyuan, and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation, while treated conventionally.
• Other Symptomatic treatment
  The control group received conventional symptomatic treatment.

Primary outcome measures

• highest pain score in HC patients within 100 days of transplantation [Time frame: 100 days]

Secondary outcome measures (8)

• Weighted Pain Score (WPS) in HC within 100 days post-transplant [Time frame: 100 days]
• incidence of HC within 100 days post-transplant [Time frame: 100 days]
• Granulocyte implantation rate [Time frame: 100 days]
• Platelet implantation rate [Time frame: 100 days]
• Incidence of acute graft-versus-host disease [Time frame: 100 days]
• Cytomegalovirus (CMV)/Epstein-Barr virus (EBV) reactivation [Time frame: 100 days]
• Infection [Time frame: 100 days]
• No relapse mortality, NRM [Time frame: 100 days]

Eligibility criteria

Inclusion criteria

• Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);
• Age: 14-60 years;
• Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia (Severe aplastic anemia; severeaplasticanimin, SAA) undergoing allo-HSCT;

Exclusion criteria

• refuse to participate in this clinical study;
• The corresponding skin at the moxibustion site is broken or sensitive;
• allo-HSCT pretreated with the RIC program;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 4 centers

• Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou — Zhengzhou
• Yi Zhang — Wuhan
• Hematology Department, The First People's Hospital of Yunnan — Kunming
• Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University Sch — Hangzhou

Publications

• Chang AK, Foca MD, Jin Z, Vasudev R, Laird M, Schwartz S, Qureshi M, Kolb M, Levinson A, Bhatia M, Kung A, Garvin J, George D, Della-Latta P, Whittier S, Saiman L, Satwani P. Bacterial bloodstream infections in pediatric allogeneic hematopoietic stem cell recipients before and after implementation of a central line-associated bloodstream infection protocol: A single-center experience. Am J Infect PMID 27378008
• Mackall C, Fry T, Gress R, Peggs K, Storek J, Toubert A; Center for International Blood and Marrow Transplant Research (CIBMTR); National Marrow Donor Program (NMDP); European Blood and Marrow Transplant Group (EBMT); American Society of Blood and Marrow Transplantation (ASBMT); Canadian Blood and Marrow Transplant Group (CBMTG); Infectious Disease Society of America (IDSA); Society for Healthcare PMID 19861978
• Gutierrez-Aguirre CH, Esparza-Sandoval AC, Palomares-Leal A, Jaime-Perez JC, Gomez-Almaguer D, Cantu-Rodriguez OG. Outpatient haploidentical hematopoietic stem cell transplant using post-transplant cyclophosphamide and incidence of hemorrhagic cystitis. Hematol Transfus Cell Ther. 2022 Apr-Jun;44(2):163-168. doi: 10.1016/j.htct.2020.09.149. Epub 2020 Dec 4. PMID 33814347
• Dalianis T, Ljungman P. Full myeloablative conditioning and an unrelated HLA mismatched donor increase the risk for BK virus-positive hemorrhagic cystitis in allogeneic hematopoetic stem cell transplanted patients. Anticancer Res. 2011 Mar;31(3):939-44. PMID 21498717
• Manikandan R, Kumar S, Dorairajan LN. Hemorrhagic cystitis: A challenge to the urologist. Indian J Urol. 2010 Apr;26(2):159-66. doi: 10.4103/0970-1591.65380. PMID 20877590
• Khojasteh NH, Zakerinia M, Ramzi M, Haghshenas M. A new regimen of MESNA (2-mercaptoethanesulfonate) effectively prevents cyclophosphamide-induced hemorrhagic cystitis in bone marrow transplant recipients. Transplant Proc. 2000 May;32(3):596. doi: 10.1016/s0041-1345(00)00906-4. No abstract available. PMID 10812128
• Arango M, Cardona D. Hemorrhagic Cystitis after Haploidentical Transplantation with Post-Transplantation Cyclophosphamide: Protective Effect of MESNA Continuous Infusion. Biol Blood Marrow Transplant. 2020 Aug;26(8):1492-1496. doi: 10.1016/j.bbmt.2020.04.028. Epub 2020 May 15. PMID 32417488
• Visintini C, Venturini M, Palese A. Haemorrhagic cystitis, preventive and treatment interventions in patients undergoing haematopoietic stem cell transplantation: A scoping review. Eur J Oncol Nurs. 2019 Oct;42:50-62. doi: 10.1016/j.ejon.2019.07.005. Epub 2019 Jul 12. PMID 31446264

Identifiers

NCT: NCT06198517 · UHCT230700

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗