Study of Moxibustion to Prevent Hemorrhagic Cystitis After Allogeneic Stem Cell Transplantation in Patients Aged 14 to 60
Led by Yi Zhang · Updated on 2026-03-12
266
Participants Needed
4
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of moxibustion to prevent hemorrhagic cystitis HC in patients undergoing allogeneic hematopoietic stem cell transplantation allo-HSCT for blood diseases. This multicenter, randomized controlled study plans to enroll 266 patients aged 14 to 60 years with pernicious blood diseases or severe aplastic anemia receiving allo-HSCT. The goal is to assess whether moxibustion can reduce the incidence and severity of HC after transplantation.
Participants are randomly divided into two groups. The experimental group receives moxibustion treatment applied to specific points Zhongji, Guanyuan, and Qihai for 30 minutes daily starting the first day after HSCT until day 14 post-transplant. The control group receives conventional symptomatic treatment. Urine tests for routine analysis and viruses are collected at admission, day 1, day 14, symptom onset, and remission of HC. Routine urine tests continue every 7 days for 100 days.
During the study, researchers monitor HC symptoms daily in affected patients, including pain and severity scores, medication use, and traditional Chinese medicine evidence. Outcomes include highest pain score within 100 days post-transplant, incidence of HC, blood cell implantation rates, graft-versus-host disease, viral reactivation, infections, and mortality. Participants are followed for 100 days to evaluate these outcomes and treatment effects.
CONDITIONS
Brief Title
Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT
Research Team
Y
Yi Zhang, Dr
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Patients are fully aware of the study, participate voluntarily and sign the informed consent form
Age between 14 and 60 years
Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia undergoing allo-HSCT
You will not qualify if you...
Refusal to participate in this clinical study
Broken or sensitive skin at the moxibustion treatment sites
Patients who received reduced-intensity conditioning (RIC) before allo-HSCT
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 15 days
Participants receive moxibustion once daily for 30 minutes starting on the first day after allogeneic hematopoietic stem cell transplantation (HSCT) until the 14th day after transplantation, or receive conventional symptomatic treatment.
Daily visits for up to 15 days
Follow-up
Duration - Up to 100 days
Participants are monitored for outcomes including pain scores, incidence of hemorrhagic cystitis, graft implantation rates, graft-versus-host disease, viral reactivation, infection, and mortality for up to 100 days after transplantation.
Regular follow-up visits during the 100 days post-transplant
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
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.
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.
A new regimen of MESNA (2-mercaptoethanesulfonate) effectively prevents cyclophosphamide-induced hemorrhagic cystitis in bone marrow transplant recipients.