Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

NCT06198517 | Recruiting

• 1 other identifier: UHCT230700
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 4

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.

Conditions

Moxibustion; Hematopoietic Stem Cell Transplantation; Hemorrhagic Cystitis; Prevention

Outcome Measures

Primary Outcomes (1)

• highest pain score in HC patients within 100 days of transplantation

  highest pain score in HC patients within 100 days of transplantation

  100 days

Secondary Outcomes (8)

• Weighted Pain Score (WPS) in HC within 100 days post-transplant

  100 days

• incidence of HC within 100 days post-transplant

  100 days

• Granulocyte implantation rate

  100 days

• Platelet implantation rate

  100 days

• Incidence of acute graft-versus-host disease

  100 days

Study Arms (2)

Moxibustion

EXPERIMENTAL

Other: Moxibustion

Control

ACTIVE COMPARATOR

Other: Symptomatic treatment

Interventions

Moxibustion OTHER

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.

Moxibustion

Symptomatic treatment OTHER

The control group received conventional symptomatic treatment.

Control

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yi Zhang: lead
• The First People's Hospital of Yunnan: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator

Study Sites (4)

Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou

Zhengzhou, Henan, 450002, China

RECRUITING

Yi Zhang

Wuhan, Hubei, 430000, China

RECRUITING

Hematology Department, The First People's Hospital of Yunnan

Kunming, Yunnan, 650032, China

RECRUITING

Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

Hangzhou, Zhejiang, 311121, China

NOT YET RECRUITING

Related Publications (8)

• 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

• 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 BACKGROUND

• 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 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

• 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 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, Dr

CONTACT

+86 15639790587; zy188603@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 10, 2024
• Study Start: March 21, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)