Protocol summary

Summary
Whereas chemotherapy-induced oral mucositis is a painful and uncomfortable side effect and affects the quality of life and the patient's tolerance for continued treatment, it is important to treat this problem. This study was performed aimed to investigate the effect of L-Carnitine in the treatment of oral mucositis caused by chemotherapy. This study is double-blind randomized clinical trial and will take place on 40 patients over 18 years old and under chemotherapy referring to Imam Khomeini hospital. Blinding was conducted for groups of subjects (patients) participants to measure the outcomes of study (researchers) and data monitoring committee (Recent analysis). Inclusion criteria of the study: bedridden in Oncology unit, consent to participate in the study, without using drugs or any vitamin and mineral carnitine in the past 8 weeks, over 18 years old, Exclusion criteria: the risk of side effects such as nausea or any time the patient refuse to participate in the study. Patients before inclusion are examined of oral health and risk factors of developing oral mucositis. Patients who have inclusion criteria, based on randomized block design in two groups of 20 patients who received the drug or placebo are placed. Patients' demographic information such as age, sex, weight, diagnosis, date of hospitalization, tests, history of other diseases and medication instructions will be registered. In the first group of L-Carnitine at a dose of 3 grams per day and the second group received placebo daily for three weeks since the start of chemotherapy. Of all patients at baseline, before administration of L-Carnitine and then at intervals of one week 10 ml blood samples for biochemical evaluation and testing of the CBC is taken. The use of L-Carnitine and patient adherence to medication side effects, the incidence of mucositis grade rating according to WHO, will be checked every week . During treatment the patient received amount of L-Carnitine also be controlled.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102265914N1
Registration date: 2017-10-02, 1396/07/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-02, 1396/07/10
Registrant information
Name
Shima Hatamkhnai
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 5548
Email address
hatamkhani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Science Faculty of Pharmacy
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of L-carnitine effect on prevention of chemotherapy-induced oral mucositis , A prospective, randomized, double-blind, controlled trial
Public title
Evaluation of L-carnitine effect on prevention of chemotherapy-induced oral mucositis , A prospective, randomized, double-blind, controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Exclusion criteria: the risk of side effects such as nausea or whenever the patient refuse to participate in the study Inclusion criteria of the study: bedridden in Oncology unit, consent to participate in the study, without using drugs or any vitamin and mineral carnitine in the past 8 weeks, aged over 18 years
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Ethics Committee of Urmia University of Medical Sciences
Street address
Emergency alley, Resalat street
City
Urmia
Postal code
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
ir.umsu.rec.1395.335

Health conditions studied

1

Description of health condition studied
mucositis
ICD-10 code
k12.3
ICD-10 code description
Oral mucositis (ulcerative)

Primary outcomes

1

Description
oral mucositis
Timepoint
weekly
Method of measurement
observation

2

Description
CBC
Timepoint
weekly
Method of measurement
blood sample

Secondary outcomes

empty

Intervention groups

1

Description
l-carnitine 1gr tablets 3 times a day for 3 weeks
Category
Treatment - Drugs

2

Description
placebo 1gr tablets 3 times a day for 3 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Urmia
Full name of responsible person
Street address
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Emergency alley, Resalat street
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Urmia University of Medical Sciences
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
Faculty of Pharmacy of Urmia
Full name of responsible person
Shima Hatamkhani
Position
Clinical Pharmacist / Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Urmia University of Medical Science, Nazloo road
City
Urmia
Postal code
Phone
+98 44 3275 4990
Fax
Email
hatamkhani@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Pharmacy of Urmia University of Medical Sciences
Full name of responsible person
Shima Hatamkhani
Position
Clinical Pharmacist / Assistant Professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Urmia University of Medical Science, Nazloo road
City
Urmia
Postal code
Phone
+98 44 3275 4990
Fax
Email
hatamkhani@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Pharmacy of Urmia University of Medical Sciences
Full name of responsible person
Mahroo Ghasempour
Position
Pharm D / student
Other areas of specialty/work
Street address
2 Nr, 3rd alley, Mobin street, Saadi2 street
City
Urmia
Postal code
5719694799
Phone
+98 44 3368 1216
Fax
Email
gmr.mahroo@yahoo.com
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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