Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06198517
• Other study ID #: UHCT230700
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Wuhan Union Hospital, China
• Contact: Yi Zhang, Dr
• Phone: +86 15639790587
• Email: zy188603[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 254 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 was collected daily before cyclophosphamide administration until +14d, and blood/urine BK virus, JC virus, and adenovirus were tested at four time points: +1d, +14 days, appearance of hematuria symptom, and remission of HC, and urine routine was tested once every 7 days for all patients within three months, and severity grading should be performed for patients with Hemorrhagic cystitis (HC), pain scores, and the main TCM evidence profile, aiming to evaluate the effectiveness of moxibustion in preventing HC in this group of patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 254
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);

2. Age: 18-55 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;

Related Conditions & MeSH terms

• Cystitis
• Hematopoietic Stem Cell Transplantation
• Hemorrhagic Cystitis
• Moxibustion
• Prevention

Intervention

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.
• Symptomatic treatment
The control group received conventional symptomatic treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of HC	incidence and severity of HC at 100 days post-transplantation	100 days