NCT03704597

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

4.8 years

First QC Date

October 10, 2018

Last Update Submit

October 10, 2018

Conditions

MyelomaMucositisCryotherapy Effect

Outcome Measures

Primary Outcomes (1)

  • Oral mucositis WHO

    Grades 3-4 oral mucositis

    day 1-14

Study Arms (2)

7-hour cryotherapy

ACTIVE COMPARATOR

Standard of care

Other: cryotherapy

2-hour cryotherapy

EXPERIMENTAL

Experimental treatment

Other: cryotherapy

Interventions

cryotherapyOTHER

Cooling of oral mucosa

2-hour cryotherapy7-hour cryotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30718802DERIVED

MeSH Terms

Conditions

Neoplasms, Plasma CellMucositis

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

March 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 30, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10