Our purpose in this double blinded randomized study is to evaluate the N-acetyl cysteine effect on mucositis prevention in patient with acute myeloid leukemia (AML) & acute lymphoblastic leukemia (ALL) & Myelodysplastic syndrome (MDS)
whose received Busulfan and/or Cyclophosphamide before Hematopoietic stem cell transplantation (HSCT) in Shariati Teaching Hospital, Tehran, Iran.
Sixty-four patients will be randomized in two groups with balanced block randomization method. One group will receive N-acetyl cysteine IV(100mg/kg) and another group will receive placebo per day. Therapy will start on the morning before starting chemotherapy and will continue until day +15.
Response assessment will include: Mucositis, glutathione peroxidase levels in the serum and infectious complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303301030N13
Registration date:2013-04-10, 1392/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-10, 1392/01/21
Registrant information
Name
Mahdi Jalili
Name of organization / entity
Hematology-Oncology & SCT Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2662
Email address
m_jalili@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology-Oncology and SCT Research Center
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of N-acetyl cysteine in preventing the incidence and severity of mucositis in patients undergoing bone marrow transplantation
Public title
The effect of N-acetyl cysteine in preventing mucositis in patients undergoing bone marrow transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients receiving chemotherapy regimens (Endoxane- busulfan) in bone marrow transplantation.
2- The patient over the 18 years old of age.
3-Informed consent forms signed by the patients.
Exclusion:
1- Participating in other clinical trial (drug or supplement)
2- Dissatisfaction of patient.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hematology-Oncology and SCT Research Center Ethics Committee
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
91/4/11
Health conditions studied
1
Description of health condition studied
Mucositis (oral)
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
2
Description of health condition studied
AML
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukaemia
3
Description of health condition studied
ALL
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia
4
Description of health condition studied
MDS
ICD-10 code
D46
ICD-10 code description
Myelodysplastic syndromes
Primary outcomes
1
Description
Oral mucositis
Timepoint
Daily at the first day of chemotherapy until the patients discharged
Method of measurement
Clinical observation
Secondary outcomes
1
Description
Glutathione peroxidase serum level
Timepoint
At the first day of admission and 14 days after the transplantation
Method of measurement
Lab Test (ng/dl)
2
Description
Fever incidence
Timepoint
Daily until discharg
Method of measurement
Measurement of oral temperature
3
Description
Duration of neutropenia
Timepoint
Daily until discharg
Method of measurement
Lab Test
4
Description
Consumption of TPN
Timepoint
During Hospitalization
Method of measurement
Medical Records
5
Description
Antibiotic consumption
Timepoint
During Hospitalization
Method of measurement
Medical Records
Intervention groups
1
Description
N-acetyl cysteine IV 00mg/kg daily
Category
Treatment - Drugs
2
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology-Oncology and SCT Research Center
Full name of responsible person
Amirhossein Moslehi
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology Oncology and SCT Research Center
Full name of responsible person
Zohreh Shahabi
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology Oncology and SCT Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hematology Oncology and SCT Research Center
Full name of responsible person
Amirhossein Moslehi
Position
ParmD
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
horcbmt@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology Oncology and SCT Research Center
Full name of responsible person
Molok Hajibabaei
Position
Clinical pharmacy /associated prof
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
horcbmt@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hematology-Oncology and SCT Research Center
Full name of responsible person
Mahdi Jalili
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital, Kargar Ave
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)