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Protocol for a randomised controlled trial to study cryoprevention of chemotherapy-induced oral mucositis after autologous stem cell transplantation
Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing.ORCID iD: 0000-0003-2960-4994
2019 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 18, no 8, article id e021993Article in journal (Refereed) Published
Abstract [en]

Introduction A majority of patients who receive myeloablative therapy prior to hematopoetic stem cell transplantation develop oral mucositis (OM). This adverse cytotoxic effect manifests as oral mucosal erythema and ulcerations and frequently necessitates high doses of morphine for pain alleviation. OM may also interfere with food intake and result in parenteral nutrition, weight loss and impaired quality of life. To date, there have been a few studies of evidence-based interventions for prevention of OM. Cooling the oral mucosa using ice chips in conjunction with chemotherapy is known to reduce the severity of OM although clinical application is still limited due to several disadvantages. The primary endpoint of this study is therefore to evaluate the efficacy of an innovative intraoral cooling device (Cooral) compared with ice cooling in reducing the degree of OM, in patients with myeloma or lymphoma.

Method and analysis A total of 180 patients from four different university hospitals in Sweden will be randomised to ice or Cooral in a proportion of 1:1. The degree of OM will be assessed at eight intraoral locations, in accordance with the Oral Mucositis Assessment Scale and WHO scale. Patients will be registered beginning at admission and will continue until discharge or until day +28. The primary variable is analysed in a multiple linear regression model. The significance level used is 5%.

Ethics and dissemination The study protocol, questionnaire, diaries and letter of invitation to participants have been reviewed by the local ethical board in Göteborg. The trial results will be published in a peer-reviewed journal and disseminated to participants.

Trial registration number NCT03203733; Pre-results.

Protocol version Version 4, 2017-06-05

Place, publisher, year, edition, pages
2019. Vol. 18, no 8, article id e021993
National Category
Health Sciences
Research subject
Health and Welfare
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URN: urn:nbn:se:du-30320DOI: 10.1136/bmjopen-2018-021993OAI: oai:DiVA.org:du-30320DiVA, id: diva2:1327582
Available from: 2019-06-19 Created: 2019-06-19 Last updated: 2019-06-24Bibliographically approved

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