Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

Not Applicable

Recruiting

• Conditions: Prevention; Hematopoietic Stem Cell Transplantation; Hemorrhagic Cystitis; Moxibustion
• Interventions: Other: Moxibustion; Other: Symptomatic treatment

• Registration Number: NCT06198517
• Lead Sponsor: Yi Zhang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-07
• Study First Posted: 2024-01-10
• Study Start: 2024-03-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-03-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 266

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxibustion	Moxibustion	-
Control	Symptomatic treatment	-

Primary Outcome Measures

Name	Time	Method
highest pain score in HC patients within 100 days of transplantation	100 days	highest pain score in HC patients within 100 days of transplantation

Secondary Outcome Measures

Name	Time	Method
Weighted Pain Score (WPS) in HC within 100 days post-transplant	100 days	Weighted Pain Score (WPS) is a method used to assess the overall pain burden by considering both the intensity and the duration of pain. Steps to Calculate WPS: Record Pain Intensity : Measure the patient's pain at various time points during the study or treatment.; Determine Time Intervals : Record the duration for which the pain was experienced at each time point.; Assign Weights : Weights are typically assigned based on the clinical significance of the time period. For example, if a patient experiences severe pain for a prolonged period, that period would have a higher weight.; Calculate the WPS: Multiply the pain intensity by the duration and the weight for each time period, and sum all these values to get the total WPS.
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
Cytomegalovirus (CMV)/Epstein-Barr virus (EBV) reactivation	100 days
Infection	100 days
No relapse mortality, NRM	100 days

Trial Locations

Locations (4)

Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou; 🇨🇳 Zhengzhou, He Nan, China

Yi Zhang; 🇨🇳 Wuhan, Hubei, China

Hematology Department, The First People's Hospital of Yunnan; 🇨🇳 Kunming, Yun nan, China

Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou; 🇨🇳 Hangzhou, Zhe Jiang, China