Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

NCT ID: NCT06198517

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-21
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Moxibustion

Group Type: EXPERIMENTAL

Moxibustion

Intervention Type: 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.

Control

Group Type: ACTIVE_COMPARATOR

Symptomatic treatment

Intervention Type: OTHER

The control group received conventional symptomatic treatment.

Interventions

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.

Intervention Type: OTHER

Symptomatic treatment

The control group received conventional symptomatic treatment.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Yunnan

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Yi Zhang

OTHER

Sponsor Role: lead

Responsible Party

Yi Zhang

Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Zhengzhou, Henan, China

Site Status: RECRUITING

Yi Zhang

Wuhan, Hubei, China

Site Status: RECRUITING

Hematology Department, The First People's Hospital of Yunnan

Kunming, Yunnan, China

Site Status: RECRUITING

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

Hangzhou, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Yi Zhang, Dr

Role: CONTACT

zy188603@163.com

+86 15639790587

Facility Contacts

Ran Zhang

Role: primary

Yi Zhang

Role: primary

jie Zhao

Role: primary

Yanmin Zhao

Role: primary

References

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Reference Type: BACKGROUND

PMID: 27378008 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 33814347 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20877590 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10812128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32417488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31446264 (View on PubMed)

Other Identifiers

UHCT230700

Identifier Type: -

Identifier Source: org_study_id