Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-08 @ 8:37 PM
Study NCT ID:
NCT03203733
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation, a Randomized Study
Sponsor:
Uppsala University
Organization:
Study Overview
Official Title:
Cryoprotection of Chemotherapy-induced Oral Mucositis After Autologous Stem Cell Transplantation, a Randomized Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: