Protocol summary

Summary
We will conduct a double-blind, randomized, placebo-controlled trial to evaluate the erythropoietin mouthwash effect on oral mucositis (OM) incidence and severity in 80 patients with hematological malignancies, undergoing autologous hematopoietic SCT (HSCT).A total of 80 adult patients with NHL, hodgkin disease (HD) or multiple myeloma (MM), undergoing autologous HSCT, are neededto enroll in the study. Major inclusion criteria are age of at least 18 years old, patients with NHL, HD or MM receiving conditioning chemotherapy before autologousHSCT and signing written informed consent. Major exclusion criteria areKarnofsky performance status <70% or participation in another study using an unlicensed product.Patients will receive either erythropoietin mouthwash (50 IU/mL, 15 ml four times a day) (n = 40) or placebo (n = 40) from the starting day of high dose chemotherapy until day +14 after transplantation.OM incidence, severity and duration will be evaluated as primary study outcomes using five-grade World Health Organization (WHO) oral toxicity scale. Several indices will be assessed as secondary outcomes including the duration of ANC under 500 cells/mm3, neutrophil and platelet engraftment time, the incidence and duration of fever and length of hospital stay.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042518842N8
Registration date: 2015-05-03, 1394/02/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-03, 1394/02/13
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology, Oncology and Stem Cell Transplantation Research Center
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of erythropoetin mouthwash in preventing the incidence and decreasing severity of mucositis in patients undergoing autologous bone marrow transplantation
Public title
Evaluation of the effect of erythropoetin mouthwash in mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: age of at least 18 years old; patients with NHL, HD or MM receiving conditioning chemotherapy before autologousHSCT; signing written informed consent. exclusion criteria: Karnofsky performance status <70% or participation in another study; using an unlicensed product.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethic Committee Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Tehran, Iran ‎
City
Tehran
Postal code
Approval date
2015-04-25, 1394/02/05
Ethics committee reference number
9011358003-143850

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
Non-Hodgkin lymphoma
ICD-10 code
C85.9
ICD-10 code description
Non-Hodgkin lymphoma, unspecified

3

Description of health condition studied
Hodgkin lymphoma
ICD-10 code
C81.9
ICD-10 code description
Hodgkin lymphoma, unspecified

Primary outcomes

1

Description
incidence, severity and duration of oral mucositis
Timepoint
The starting day of preparing chemotherapy until day +21 after transplantation
Method of measurement
Daily oral examination based on the WHO criteria for grading mucositis

Secondary outcomes

1

Description
neutrophil and platelet engraftment
Timepoint
The starting day of preparing chemotherapy until day +21 after transplantation
Method of measurement
CBC test

2

Description
Duration of neutropenia
Timepoint
The starting day of preparing chemotherapy until day +21 after transplantation
Method of measurement
CBC test

3

Description
Duration of fever due to neutropenia
Timepoint
The starting day of preparing chemotherapy until day +21 after transplantation
Method of measurement
Temperatures measured under the tongue

4

Description
Duration of hospitalization
Timepoint
Discharge Time
Method of measurement
The number of hospitalization days

Intervention groups

1

Description
erythropoietin mouthwash (50 IU/mL, 15 ml four times a day from starting day of preparing chemotherapy until day +14 after transplantation
Category
Prevention

2

Description
pelacebo mouthwash (50 IU/mL, 15 ml four times a day from starting day of preparing chemotherapy until day +14 after transplantation
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hematology, Oncology and Stem Cell Transplantation Research Center
Full name of responsible person
Hesamoddin Hosseinjani
Street address
Kargar Shomali St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hematology, Oncology and Stem Cell Transplantation Research Center
Full name of responsible person
Mohammad Vaezi
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 Stem Cell Transplantation 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
School of Pharmacy, Tehran University of Medical Sciences
Full name of responsible person
Hesamodin Hosseinjani
Position
Board of Clinical Pharmacy
Other areas of specialty/work
Street address
Keshavrarz St
City
Tehran
Postal code
Phone
+98 21 6643 5807
Fax
Email
hosseinjanih@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Pharmacy of Tehran University of Medical Sciences
Full name of responsible person
Molouk Hajbabaii
Position
Boardof Clinical Pharmacy
Other areas of specialty/work
Street address
N.92, kheradmand jonoubi St
City
Tehran
Postal code
Phone
00
Fax
Email
hajibaba@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hematology, Oncology and Stem Cell Transplantation Research Center
Full name of responsible person
Leyla Sharifi Aliabadi
Position
Nurse
Other areas of specialty/work
Street address
Shariati Hosspital
City
Tehran
Postal code
14114
Phone
+98 21 8490 2669
Fax
Email
ctu@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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