Cryotherapy Against Oral Mucositis After High-dose Melphalan

Not Applicable

• Conditions: Myeloma; Cryotherapy Effect; Mucositis
• Interventions: Other: cryotherapy

• Registration Number: NCT03704597
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2014-03-01
• Status Verified: 2018-10
• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Study First Posted: 2018-10-15
• Last Update Posted: 2018-10-15
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

myeloma, autologous HSCT -

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-hour cryotherapy	cryotherapy	Experimental treatment
7-hour cryotherapy	cryotherapy	Standard of care

Primary Outcome Measures

Name	Time	Method
Oral mucositis WHO	day 1-14	Grades 3-4 oral mucositis