Moxibustion in the Treatment of Hemorrhagic Cystitis After Allo-HSCT

NCT06241274 | Recruiting

• 1 other identifier: UHCT230698
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moxibustion; Hematopoietic Stem Cell Transplantation; Hemorrhagic Cystitis; Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Moxibustion

EXPERIMENTAL

Subjects received symptomatic supportive treatment combined with moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.

Other: Moxibustion; Other: Symptomatic supportive treatment

Interventions

Moxibustion OTHER

Subjects received moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.

Moxibustion

Symptomatic supportive treatment OTHER

Symptomatic supportive treatment.

Moxibustion

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients were fully aware of the study, participated voluntarily, and signed the informed consent form;
• Age: 18-55 years old;
• patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation;

You may not qualify if:

• refusal to participate in this clinical study;
• broken or sensitized skin corresponding to the moxibustion site;
• allogeneic hematopoietic stem cell transplantationpatients pretreated with the Reduced-intensity conditioning.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Yi Zhang

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 27378008 BACKGROUND

• 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.

  PMID: 19861978 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 17845642 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 27293460 BACKGROUND

• 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.

  PMID: 34762387 BACKGROUND

• 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.

  PMID: 33360387 BACKGROUND

MeSH Terms

Conditions

Cystitis, Hemorrhagic

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Central Study Contacts

Yi Zhang

CONTACT

+86 15639790587; zy188603@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: February 5, 2024
• Study Start: August 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)