Cryotherapy Against Oral Mucositis After High-dose Melphalan
Primary Purpose
Myeloma, Mucositis, Cryotherapy Effect
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Myeloma
Eligibility Criteria
Inclusion Criteria: myeloma, autologous HSCT -
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
7-hour cryotherapy
2-hour cryotherapy
Arm Description
Standard of care
Experimental treatment
Outcomes
Primary Outcome Measures
Oral mucositis WHO
Grades 3-4 oral mucositis
Secondary Outcome Measures
Full Information
NCT ID
NCT03704597
First Posted
October 10, 2018
Last Updated
October 10, 2018
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03704597
Brief Title
Cryotherapy Against Oral Mucositis After High-dose Melphalan
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
We searched MEDLINE and PubMed with the following phrases: "oral mucositis", "oral toxicity", "cryotherapy", "myeloma", "autologous haematopoietic stem cell transplantation", "randomised trial" and "high-dose melphalan".
Oral mucositis, which is a side effect of high-dose chemotherapy, has a major negative impact on the quality of life and survival of patients who undergoing autologous haematopoietic stem cell transplantation (auto-HSCT). For patients with myeloma cryotherapy gives a significant reduction in oral mucositis. The mechanism of action is suggested to be vasoconstriction that is induced by the cooling of the oral mucosa, thereby protecting it from the cytotoxic effects of the chemotherapy. The therapeutic efficacy of cryotherapy in this setting has been confirmed in several trials, it is currently regarded as the standard of care prophylactic regimen for oral mucositis in patients undergoing auto-HSCT for myeloma. However, the long duration of the treatment (7 hours), as reported in the original, placebo-controlled study in 2006, has been associated with significant discomfort for the patients, with negative consequences for compliance.
Uncontrolled trials have previously tested cryotherapy for less than 7 hours in patients with myeloma who receive auto-HSCT. At the time of the planning of the current study in 2014, those results were not yet confirmed in any randomised trial. However last year a randomised trial was published, showing that 2-hour cryotherapy is equally as effective as 6-hour cryotherapy in preventing oral mucositis in patients with myeloma who are treated with high-dose melphalan. The present prospective, randomised study aimed to investigate whether 2 hours of cryotherapy is as effective as 7 hours of cryotherapy in protecting against oral mucositis those patients who are subjected to high-dose melphalan as a conditioning agent for auto-SCT for myeloma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma, Mucositis, Cryotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
7-hour cryotherapy
Arm Type
Active Comparator
Arm Description
Standard of care
Arm Title
2-hour cryotherapy
Arm Type
Experimental
Arm Description
Experimental treatment
Intervention Type
Other
Intervention Name(s)
cryotherapy
Intervention Description
Cooling of oral mucosa
Primary Outcome Measure Information:
Title
Oral mucositis WHO
Description
Grades 3-4 oral mucositis
Time Frame
day 1-14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: myeloma, autologous HSCT -
Exclusion Criteria:
-
12. IPD Sharing Statement
Citations:
PubMed Identifier
30718802
Citation
Johansson 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.
Results Reference
derived
Learn more about this trial
Cryotherapy Against Oral Mucositis After High-dose Melphalan
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