Cryotherapy Against Oral Mucositis After High-dose Melphalan

NCT ID: NCT03704597

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2018-12-30

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.

Conditions

Myeloma; Mucositis; Cryotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

7-hour cryotherapy

Standard of care

Group Type: ACTIVE_COMPARATOR

cryotherapy

Intervention Type: OTHER

Cooling of oral mucosa

2-hour cryotherapy

Experimental treatment

Group Type: EXPERIMENTAL

cryotherapy

Intervention Type: OTHER

Cooling of oral mucosa

Interventions

cryotherapy

Cooling of oral mucosa

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jan-Erik Johansson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 30718802 (View on PubMed)

Other Identifiers

Sahlgrenska

Identifier Type: -

Identifier Source: org_study_id