The evaluation of efficacy of prophylactic use of N-Acetyl-cysteine on accelerating platelet engraftment in multiple myeloma and lymphoma patients post Auto-HSCT in comparison to placebo group
Design
Clinical trial with control group, with parallel group, triple blinded, phase 3 with 30 patients, for randomization Random Allocation software is used.
Settings and conduct
After randomization volunteers who accept to participate in the study , and are admitted in transplant ward at Omid Hospital in Isfahan, Iran, in addition to routine care and treatment based on triple blinded fashion (patients, investigators, health care providers, analyzer are blinded) receive N acetyl cysteine (intervention group) or placebo(control group). During admition platelet will be checked daily and after that weekly at-least for 3 weeks,after gathering data, the statistics will analyze qualitative data by Wallis-kruskal and quantitative data with unilateral variance. A p-value less than 0.05 (typically ≤ 0.05) is statistically significant.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with multiple myeloma or lymphoma who are eligible for Auto-HSCT
Exclusion criteria: history of allergic reaction to N-Acetyl cysteine or its ingredients, or Bronchial Asthma
Intervention groups
Intervention group in addition to routine treatment receive N-Acetyl cysteine oral 400 mg q 8 hour one week before and two weeks after auto-HSCT.
like intervention group , control group receive routine treatment in addition to placebo in the same schedule.
Main outcome variables
The days which platelet infusion are not required.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211123053165N1
Registration date:2021-12-22, 1400/10/01
Registration timing:registered_while_recruiting
Last update:2021-12-22, 1400/10/01
Update count:0
Registration date
2021-12-22, 1400/10/01
Registrant information
Name
Rasoul Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3226 1922
Email address
rasoolqasemian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N Acetyl cysteine on platelet engraftment post autologous bone marrow transplantation in comparison to control group
Public title
Effect of N-Acetyl-cysteine On platelet Engraftment post Auto-HSCT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Multiple Myeloma who are eligible for Auto-HSCT
Patients with Lymphoma who are eligible for Auto-HSCT
Exclusion criteria:
History Of Allergic Reaction to N-Acetyl cysteine or its ingredients
History of Bronchial Asthma
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
After calculating sample size, because there are intervention and control groups, these data is inserted in online Random Allocation software.The software randomly give two sequences of number, which distributed in two groups.According to entrance of every patient,assigns a number to each volunteer.Then regard to the number is belonged to which group , patients will be in control or intervention group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The company that produced drug and placebo, packed them in different color boxes and with them send us a closed letter in which explain each color is related to drug or placebo. We will open this letter at the end of study, when the data analyzed.So participants, investigators, health care providers,information gathering responsible and Analyzer have been blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
No 20, Farhangian A, Irajmirza Alley, Kahran Alley, North Golzar
City
Esfahan
Province
Isfehan
Postal code
8154916877
Approval date
2021-11-12, 1400/08/21
Ethics committee reference number
IR.MUI.MED.REC.1400.627
Health conditions studied
1
Description of health condition studied
MULTIPLE MYELOMA
ICD-10 code
C90.0
ICD-10 code description
Multiple myeloma
2
Description of health condition studied
LYMPHOMA
ICD-10 code
C81
ICD-10 code description
Hodgkin lymphoma
3
Description of health condition studied
Auto-Hsct
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Median Platelet number post auto-Hsct
Timepoint
During admition daily then weekly for at least 3 weeks
Method of measurement
complete blood count test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with Multiple Myeloma or Lymphoma that their diseases are in complete remission and are candidate of Auto-HSCT, will be received N-Acetyl cysteine tablets, in form of 200mg tablets which produced by Toliddarou pharmaceutical company, 400 mg every 8 hours(21 days).
Category
Treatment - Drugs
2
Description
Control group: patients with Multiple Myeloma or Lymphoma that their diseases are in complete remission and are candidate of Auto-HSCT, will be received Placebo tablets, in the same form as control group, which produced by Toliddarou pharmaceutical company, two tablets every 8 hours(21 days).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Rasoul Ghasemian
Street address
Motahari
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3235 5125
Email
rasoolqasemian@yahoo.com
Web page address
https://omid.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
No 4, Ishan Medical University, Hezarjirib Street
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
siavash@med.mui.ac.ir
Web page address
https://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasoul Ghasemian
Position
Hematology-Oncology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
No 20, Farhangian A, Irajmirza Ave,Kahran Ave, Golzar street
City
Esfahan
Province
Isfehan
Postal code
8154916877
Phone
+98 31 3226 1922
Email
rasoolqasemian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohamadsaleh Peikar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Motahari street
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3235 5125
Email
mspeikar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasoul Ghasemian
Position
Hematology-Oncology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
No. 20, Farhangian A, Irajmirza Ave, Kahran Ave, Golzar street
City
Esfahan
Province
Isfehan
Postal code
8154916877
Phone
+98 31 3226 1922
Email
rasoolqasemian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
only data related to main outcome will be shared.
When the data will become available and for how long
3months post published results
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
Analyzing the revealed data is not allowed.
From where data/document is obtainable
Rasoul Ghasemian, Isfahan Medical university
rasoolqasemian@yahoo.com
What processes are involved for a request to access data/document