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Efficacy and Safety of Extended Cryotherapy versus Standard Oral Care for the Prevention of Oral Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation with Cyclophosphamide-Containing Conditioning Regimens

Efficacy and Safety of Extended Cryotherapy versus Standard Oral Care for the Prevention of Oral Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation with Cyclophosphamide-Containing Conditioning Regimens

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127512
Enrollment
Unknown
Registered
2026-07-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral mucositis

Interventions

Control group:standard oral care
Treatment group:extended cryotherapy

Sponsors

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT); 3. Conditioning regimen containing cyclophosphamide; 4. Life expectancy > 6 months; 5. Karnofsky performance status score >= 70%.

Exclusion criteria

Exclusion criteria: 1. History of prior radiotherapy to the head and neck; 2. Active oral infection or severe periodontal disease; 3. Cryoglobulinemia or cold-sensitive disorders; 4. Inability to tolerate ice-water-based procedures (e.g., dysphagia); 5. Conditioning regimen containing melphalan.

Design outcomes

Primary

MeasureTime frame
Incidence of oral mucositis within 28 days post?transplant;

Secondary

MeasureTime frame
total length of hospital stay;Days of parenteral nutrition;Cryotherapy-related adverse events (e.g., frostbite, cold intolerance);The Days of Neutrophil engraftment;median time to onset of OM;all cause mortality of 100 days;maximum severity of OM;cumulative opioid consumption;

Countries

China

Contacts

Public ContactJing Zhao

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

zhaojingyb@126.com+86 571 87233801

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026