Evaluation of the Effectiveness of Melatonin on engraftment and Stem Cell Collection in Patients Undergoing autologous Bone Marrow Transplant (ABMT)
Design
A randomized triple blind clinical trial with a parallel group design of 48 patients, undergoing ABMT
Settings and conduct
This study perform at BMT ward of Ayatollah Taleghani Teaching Hospital in a randomized, triple blind (patient, physician and researcher) in two groups of drug and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria contain:
1. Age between 18 to 70 years
2. Malignancy diagnosis according oncologist specialist
3. Non-pregnancy and lactation
4. Informed consent to participate in the study
Exclusion criteria contian:
1.Not using Melatonin or placebo for three doses Consecutively
2. Unable to keep sublingual tablets under the tongue
3. Taking more than 2 sedative or hypnotic medicine (example: Benzodiazepines) regulary over a week
Intervention groups
In the intervention group, patients receive Melatonin (manufactured by Vana Daru Gostar) along with the G-CSF protocol. The administration of Melatonin starts 5 days prior to cell collection with dose of 3 mg twice daily concomitant with G-CSF, then 9 mg 30 minutes prior to cell collection and finally twice daily dose of 3 mg sublingual until engraftment.
In the Control group, patients receive placebo along with the G-CSF protocol. The administration of placebo starts 5 days prior to cell collection with dose of one tablet twice daily concomitant with G-CSF, then 3 tablet 30 minutes prior to cell collection and finally twice daily dose of one tablet sublingual until engraftment.
Main outcome variables
Evaluation of CD34 changes, Engraftment duration, Dose requirement of G-CSG, Sleep disturbance according to Insomnia Severity Index (ISI), Anxeity Score according to Hospital Anxiety and Depression Scale (HADS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N20
Registration date:2020-02-20, 1398/12/01
Registration timing:registered_while_recruiting
Last update:2020-02-20, 1398/12/01
Update count:0
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-05, 1398/08/14
Expected recruitment end date
2020-11-04, 1399/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Melatonin on the stem cells collection and engraftment in autologous hematopoietic stem cells transplant recipients
Public title
Effect of Melatonin on autologous hematopoietic stem cells transplant success
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of malignancy according to expert opinion and Laboratory data
Fill in the Consent
Ages 18-70 years
Exclusion criteria:
Not using of Melatonin for 3 doses consecutive
Inability to use sublingual tablets
Taking more than 2 sedative or hypnotic medicine (example: Benzodiazepines) regulary over a week
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use Cluster block randomization method by online statistical software. So, we have 8 blocks with block size 6, that 3 participants receive Melatonin and the others receive placebo.
The allocation and distribution of blocks are done and a code is generated for each sample by online software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, participants, principle investigator initiated trials, healthcare providers (Physicians and Nurses), data collectors, outcome assessors are unaware of the study groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Pharmacy and Nursing & Midwifery - Shahid Beheshti University of Medical Sciences
Street address
Faculty of Pharmacy, Niayesh intersection, Valiasr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-11-04, 1398/08/13
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.214
Health conditions studied
1
Description of health condition studied
Autologous Hematopoietic Stem Cells Transplant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
CD34 changes
Timepoint
Daily
Method of measurement
Blood sample and use a Laboratory Kit
2
Description
Engraftment duration
Timepoint
Daily
Method of measurement
Blood sample
3
Description
GCSF dose requirement
Timepoint
Daily
Method of measurement
Dose requirement according physician orders
Secondary outcomes
1
Description
Sleep disturbance during transplant
Timepoint
Weekly
Method of measurement
Insomnia Severity Index (ISI)
2
Description
Anxiety score during transplantation
Timepoint
Weekly
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
Intervention groups
1
Description
In the intervention group, patients receive Melatonin (manufactured by Vana Daru Gostar) along with the G-CSF protocol. The administration of sublingual Melatonin starts 5 days prior to cell collection with dose of 3 mg twice daily concomitant with G-CSF, then 9 mg sublingual 30 minutes prior to cell collection and finally twice daily dose of 3 mg sublingual tablet until engraftment.
Category
Treatment - Drugs
2
Description
In the Control group, patients receive placebo along with the G-CSF protocol. The administration of placebo starts 5 days prior to cell collection with dose of one sublingual tablet twice daily concomitant with G-CSF, then 3 sublingual tablets 30 minutes prior to cell collection and finally twice daily dose of one sublingual tablet until engraftment