Clinical trial NCT03203733: Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation, a Randomized Study
Official title: Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation, a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy Effect
Keywords: Oral Mucositis , cooling, cryotherapy
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 182
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates, among study patients with lymphoma or myeloma undergoing autologous SCT, whether cooling oral mucosa with a cooling device compared with ice cubes/crushed ice or ice pop succeeds in reducing the degree of oral mucositis (OM) according to the Oral Mucositis Assessment Scale (OMAS) total,degree of OM according to World Health Organisation (WHO), tolerability of either cooling method. The study is also aiming to , patients subjective experience of OM, rating of general quality of life and oral pain, number of days with total parenteral nutrition (TPN), number of hospital days, total dose of opioids, and C reactive protein during time in care.

Finally, the study aims to evaluate weight loss, Leukocyte particle concentration, number of days until bone marrow response, S-albumin, and body temperature.

Detailed description: The degree of OM is assessed at eight intraoral locations, in accordance with the Oral Mucositis Assessment Scale (OMAS) (graded 0-3 for ulceration and 0-2 for erythema). 0 corresponds to "normal" while 3 and 2 are "sore \>3 cm2" and "severe erythema" respectively. The assessment generates both an average for OMAS ulceration (0-3) and OMAS erythema (0-2) and a total average OMAS (0-5), which is the mean of both ulceration and erythema.

Besides OMAS, ulceration and erythema are also assessed with the WHO scale (graded 0-4) where 0 is "no mucositis" and 4 is "ulceration, total parenteral nutrition".

Assessment with OMAS and WHO is done by a dentist, blinded to treatment group, three times a week, for example, Monday, Wednesday, Friday, until discharge or at most day +28.Assessment with the WHO is also performed by nurses who are not blinded to the treatment group, three times a week.

Furthermore, the patients, after cooling ends, assess the tolerability of the respective cooling method with the aid of a questionnaire developed for the study. The questionnaire is intended to give some idea of any discomfort or side effects the patients feel as a result of the cooling method.

The patients assess their perception of oral problems daily with the aid of specific questions in a diary developed for the study. The questions are intended to give a picture of the effect of OM on the patient's general status.

General quality of life is assessed twice during the study period, before the start of treatment and at discharge, with a validated quality of life instrument.

Oral pain is assessed with a visual analog scale (VAS) with the extremes graded on a 10-figure scale (0-10) where 0 is "no pain" and 10 is "unbearable pain".

Information about total parenteral nutrition (TPN), number of hospital days, total dose of opioids, weight loss, and body temperature will be retrieved from patient records. Laboratory results of blood tests will be retrieved from each department's register of test results.

The result of the assessments is documented on sheets for the purpose in a patient's individual kardex.

Eligibility criteria: Inclusion Criteria:

* Patients between 16 and 99 years of age diagnosed with lymphoma or myeloma
* Able to communicate in Swedish
* Treated with bis-chloroethylnitrosourea, etoposide, cytarabine, and cyclophosphamide(BEAC) or bis-chloroethylnitrosourea, etoposide, cytarabine, and melphalan (BEAM) (lymphoma diagnosis), melphalan (myeloma diagnosis), before stem cell transplantation (SCT)

Exclusion Criteria:

* Patients who do not understand oral and written information in Swedish.

Primary outcomes:
measure: OM according to OMAS total during 28 days or until discharge
timeFrame: 28 days or until discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet in Oslo
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Section for Orofacial diagnosis and surgery, Karolinska University Hospital
name: Karin Garming Legert, Dentist, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oral Medicine Clinic, Department of Odontology, University of Gothenburg
name: Mats Jontell, dentist
role: STUDY_DIRECTOR
affiliation: Section for Hematology & Coagulation, Uppsala University Hospital
name: Torbjörn Karlsson, MD physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Hematology Center, M54, Karolinska University Hospital
name: PA Broliden, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
affiliation: Section for Hematology, Linköping University Hospital
name: Franz Rommel, physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Section for Hematology, Örebro University Hospital
name: Erik Ahlstrand, physician
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rubenstein EB, Peterson DE, Schubert M, Keefe D, McGuire D, Epstein J, Elting LS, Fox PC, Cooksley C, Sonis ST; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer. 2004 May 1;100(9 Suppl):2026-46. doi: 10.1002/cncr.20163.
citation: Walladbegi J, Henriksson R, Tavelin B, Svanberg A, Larfors G, Jadersten M, Schjesvold F, Mahdi A, Garming Legert K, Peterson DE, Jontell M. Efficacy of a novel device for cryoprevention of oral mucositis: a randomized, blinded, multicenter, parallel group, phase 3 trial. Bone Marrow Transplant. 2022 Feb;57(2):191-197. doi: 10.1038/s41409-021-01512-6. Epub 2021 Nov 3.
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