Clinical trial · Interventional
Cryotherapy Against Oral Mucositis After High-dose Melphalan
Cryotherapy as Prophylaxis Against Oral Mucositis After High-dose Melphalan and Autologous Stem Cell Transplantation for Myeloma: a Randomised, Open-label, Phase 3, Non-inferiority Trial Comparing Two and Seven Hours of Cryotherapy.
NCT03704597CI-TRIAL-00035280unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this prospective, randomised, controlled, open-label, Phase III, non-inferiority clinical trial trial patients with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 hours or 2 hours . Oral mucositis was evaluated prospectively.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cryotherapy Effect | — | UNRESOLVED | — |
| Mucositis | — | UNRESOLVED | — |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 7-hour cryotherapy
- description
- Standard of care
- interventionNames
- Other: cryotherapy
- type
- EXPERIMENTAL
- label
- 2-hour cryotherapy
- description
- Experimental treatment
- interventionNames
- Other: cryotherapy
Primary outcomes (1)
- measure
- Oral mucositis WHO
- timeFrame
- day 1-14
- description
- Grades 3-4 oral mucositis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: myeloma, autologous HSCT - Exclusion Criteria: \-
References
Publications (1)
- DERIVEDJohansson JE, Bratel J, Hardling M, Heikki L, Mellqvist UH, Hasseus B. Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial. Bone Marrow Transplant. 2019 Sep;54(9):1482-1488. doi: 10.1038/s41409-019-0468-6. Epub 2019 Feb 4. PMID 30718802