Clinical trial NCT06198517: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Moxibustion
Hematopoietic Stem Cell Transplantation
Hemorrhagic Cystitis
Prevention
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Yunnan
name: The First Affiliated Hospital of Zhengzhou University
name: First Affiliated Hospital of Zhejiang University
First posted: 2024-01-10
Enrollment: 266
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);
2. Age: 14-60 years;
3. 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:

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

Primary outcomes:
measure: highest pain score in HC patients within 100 days of transplantation
timeFrame: 100 days
Secondary outcomes:
measure: Weighted Pain Score (WPS) in HC within 100 days post-transplant
timeFrame: 100 days
measure: incidence of HC within 100 days post-transplant
timeFrame: 100 days
measure: Granulocyte implantation rate
timeFrame: 100 days
measure: Platelet implantation rate
timeFrame: 100 days
measure: Incidence of acute graft-versus-host disease
timeFrame: 100 days
measure: Cytomegalovirus (CMV)/Epstein-Barr virus (EBV) reactivation
timeFrame: 100 days
measure: Infection
timeFrame: 100 days
measure: No relapse mortality, NRM
timeFrame: 100 days
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou
state: He Nan
city: Wuhan
country: China
facility: Yi Zhang
state: Hubei
city: Kunming
country: China
facility: Hematology Department, The First People's Hospital of Yunnan
state: Yun nan
city: Hangzhou
country: China
facility: Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
state: Zhe Jiang
Study officials:
References:
citation: 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 Control. 2016 Dec 1;44(12):1650-1655. doi: 10.1016/j.ajic.2016.04.229. Epub 2016 Jul 1.
citation: 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 Epidemiology of America (SHEA); Association of Medical Microbiology and Infectious Diseases Canada (AMMI); Centers for Disease Control and Prevention (CDC). Background to hematopoietic cell transplantation, including post transplant immune recovery. Bone Marrow Transplant. 2009 Oct;44(8):457-62. doi: 10.1038/bmt.2009.255. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.