Effect of Oral Cryotherapy and Normal Saline Mouth Rinse on Chemotherapy –Induced Oral Mucositis in Patients with Autologous Blood Stem-Cell Transplantation: A Randomized clinical Trial
This clinical trial study will perform for determining the effect of ice chips and Normal Saline mouth rinse on oral mucositis in patients with autologous blood Stem-Cell transplantation, after approval and ethics committee's confirmation. Participants include patients with multiple myeloma, Hodgkin and non Hodgkin lymphoma which will be chosen by convenience sampling based on inclusion criteria and will be allocated to two groups randomly. One group by cryotherapy and the other by Normal saline will have mouth care. At first, the demographic form of participants will be filled by the researcher. During first chemotherapy process, in intervention group (ice-therapy) the ice chips will place in the mouth by the nurse, from 5 minutes before, during and 5 minutes after each administration of chemotherapy period continuously (mean time 20-40 Min) with considering his tolerance and with 20 minutes interval resting. The ice therapy will continue based on chemotherapy protocol. In both groups the usual oral care will continue during study. For determining the severity of mucositis, before intervention, third day after chemotherapy process, moreover every week until 3 weeks after chemotherapy period, WHO mucositis Scale will be filled by the researcher in both groups in 5 degree (0-4) then demographic data and WHO scale will compare and analyze by statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307165665N4
Registration date:2013-10-15, 1392/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-15, 1392/07/23
Registrant information
Name
Sima Lakdizaji
Name of organization / entity
Tabriz University of Medical Sciences, Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
laks@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences - Nursing and Midwifery Faculty- Vice chancellor for research
Expected recruitment start date
2013-10-06, 1392/07/14
Expected recruitment end date
2014-04-06, 1393/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Oral Cryotherapy and Normal Saline Mouth Rinse on Chemotherapy –Induced Oral Mucositis in Patients with Autologous Blood Stem-Cell Transplantation: A Randomized clinical Trial
Public title
Effect of Oral Cryotherapy and Normal Saline Mouth Rinse on Chemotherapy –Induced Oral Mucositis in Patients with Blood Stem-Cell Transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Consciousness; Age between 18 to 70 years; To have Hodgkin's, non Hodgkin's lymphoma or Multiple Myeloma with the same grades; To have healthy oral mucous; Isolation of participants from the beginning of the project; To have Similar Chemotherapy properties; To have the same Autologous transplantation protocols
Exclusion criteria: Participants’ dissatisfaction; Loss of consciousness; Suffering from other diseases during treatment; use of narcotic analgesics continuously before the study; Combined therapies such as radiation therapy at the time of study; Fever, neutropenia and mucositis before starting treatment; To have respiratory diseases such as asthma and oral infections; Systemic diseases effective on oral tissues, especially periodontal disease; To have chemotherapy two weeks before transplantation; Change in treatment protocol during the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Tabriz University of Medical Sciences
Street address
Research Deputy- Amoozesh building- Tabriz University of Medical Sciences- Daneshgah Ave.- Tabriz
City
Tabriz
Postal code
Approval date
2013-09-17, 1392/06/26
Ethics committee reference number
9299
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
k12.3
ICD-10 code description
oral mucositis-ulcerative
Primary outcomes
1
Description
Oral Mucositis
Timepoint
before chemotherapy and 3rd, 7th, 14th and21th days folowing end of chemotherapy
Method of measurement
WHO Mucositis Scale
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
During 4 days, every day following end of chemotherapy
Method of measurement
checklist
Intervention groups
1
Description
In intervention group (ice-therapy) the small ice pieces will prepare in plastic freezer disposable formats (casts) with ready clean mineral water in dedicated refrigerator of each patient. During chemotherapy process, for cooling the oral cavity, the ice chips will place in mouth by the nurse, from 5 minutes before, during and 5 minutes after each intravenous administration of chemotherapy period continuously (mean time 20-40 Min) with considering his tolerance and with 20 minutes interval resting. The ice therapy maintains will continue based chemotherapy protocol. As the ice pieces melts it will replace with new ones. The ice pieces will prepare in a manner that would not irritate the oral cavity and could easily move in the mouth (size approximately 3*4 cm casts) will be provided in sterile containers to patients. If the participants have the prosthetic teeth, they will be asked to remove it. The usual oral care will continue after stem cell transplantation.
Category
Prevention
2
Description
In saline rinse group, the participants will be asked to rinse their mouth by a saline solution with the room temperature (23-29 centigrade degree), 30 minutes before chemotherapy to 6 hours after it, every 30 minutes by the nurse. In this way 30-50 ml of normal saline will be used in every time. The usual oral care will continue after transplantation of stem cells.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi transplantation hospital affiliate to Shiraz Medical science University
Full name of responsible person
Marzie Askarifar
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nursing and Midwifery Faculty- Vice chancellor for research
Full name of responsible person
Sima Lakdizaji
Street address
Nursing and Midwifery Faculty- Shariati Jnoobi Ave- Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing and Midwifery Faculty- Vice chancellor for research