Moxibustion in the Treatment of Hemorrhagic Cystitis After Allo-HSCT

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Clinical Study of Moxibustion in the Treatment of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06241274
• Other study ID #: UHCT230698
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: December 31, 2025

Study information

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

Clinical Trial Summary

This study was a prospective, multicenter, single-arm clinical study planned to enroll 60 patients who developed hemorrhagic cystitis after sexually allogeneic hematopoietic stem cell transplantation Patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation were given symptomatic supportive treatment combined with moxibustion covering Shenque, Zhongguo, Guanyuan, and Qihai for 30 minutes every day for 14 days and urine routine was collected every day for 14 days to assess the severity of hemorrhagic cystitis and pain scores to evaluate the effectiveness of moxibustion in treating hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• 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 were fully aware of the study, participated voluntarily, and signed the informed consent form;

2. Age: 18-55 years old;

3. patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation;

Exclusion Criteria:

1. refusal to participate in this clinical study;

2. broken or sensitized skin corresponding to the moxibustion site;

3. allogeneic hematopoietic stem cell transplantationpatients pretreated with the Reduced-intensity conditioning.

Related Conditions & MeSH terms

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

Intervention

Other:
• Moxibustion
Subjects received moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.
• Symptomatic supportive treatment
Symptomatic supportive treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

References & Publications (9)

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

Hassan Z, Remberger M, Svenberg P, Elbander M, Omazic B, Mattsson J, Conrad R, Svahn BM, Ahlgren A, Sairafi D, Aschan J, Le Blanc K, Barkholt L, Ringden O. Hemorrhagic cystitis: a retrospective single-center survey. Clin Transplant. 2007 Sep-Oct;21(5):659-67. doi: 10.1111/j.1399-0012.2007.00705.x. — View Citation

Li X, Li ZM, Tan JY, Wang T, Chen JX, Chen X, Yang L, Suen LKP. Moxibustion for post-stroke urinary incontinence in adults: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2021 Feb;42:101294. doi: 10.1016/j.ctcp.2020.101294. Epub 2020 Dec 24. — 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

Sun ZR, Wang CB, Yin HN, Luan YX, Liu YX, Gong RQ, Gong N, Wang BL, Miao CX. [Network Meta-analysis of acupuncture and moxibustion for allergic rhinitis]. Zhongguo Zhen Jiu. 2021 Nov 12;41(11):1295-302. doi: 10.13703/j.0255-2930.20200916-0002. Chinese. — View Citation

Tang B, Zhang J, Yang Z, Lu Y, Xu Q, Chen X, Lin J. Moxibustion for Diarrhea-Predominant Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2016;2016:5105108. doi: 10.1155/2016/5105108. Epub 2016 May 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core Lower Urinary Tract Symptom Score	The Core Lower Urinary Tract Symptom Score consists of 10 questions. Frequent daytime urination---0 points:<7 times;1 point:8~9 times;2 points:10~14 times;3 points:> 14 times. Nocturia---0 points:0 times/night;1 point:1 time/night;2 points: 2~3 times/night;3 points:> 3 times/night. The other 8 problems were urgency, dysuria, hesitancy, thin urine line, urge incontinence, stress incontinence, bladder pain, and urethral pain, which were rated as 0, 1, 2, and 3 according to their frequency (never, rarely, sometimes, and often).	14 days