Effects of 5-aminolevulinic acid on the quality of life in patients with glioblastoma
Design
A randomized controlled clinical trial with parallel, randomized, not blinded groups
Settings and conduct
The study is included 40 patients with glioblastoma referred to Imam Khomeini Hospital, Tehran University of Medical Sciences and Firoozgar Hospital of Iran University of Medical Sciences from September 2019 to September 2020. Patients with multiform glioblastoma are selected based on simple random sampling. Patients are randomly divided into two groups; the conventional treatment with 5-ALA and only the conventional treatments. The first group will receive 5-ALA 5 mg/kg, three hours before radiotherapy in all 30 sessions of radiation therapy. The second group will just receive conventional treatments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Randomized, obtained written consent, patients with glioblastoma multiforme.
Exclusion criteria: Patients with renal and hepatic problems, patients with serious heart diseases, patients with GFR less than 30, patients with immunodeficiency, including AIDS and hepatitis.
Intervention groups
Patients with multiform glioblastoma together the indication of radiotherapy are selected based on simple random sampling. Patients are randomly assigned to two groups; the first group, the conventional treatments together 5-ALA and the second group just the conventional treatments without 5-ALA. Patients in the first group will receive 5-ALA 5 mg/kg, three hours before radiotherapy in all 30 sessions of radiation therapy. And the second group will just receive conventional treatments.
Main outcome variables
Assessments include the quality of life؛
General information
Reason for update
Acronym
5-ALA
IRCT registration information
IRCT registration number:IRCT20140810018745N12
Registration date:2019-09-05, 1398/06/14
Registration timing:registered_while_recruiting
Last update:2019-09-05, 1398/06/14
Update count:0
Registration date
2019-09-05, 1398/06/14
Registrant information
Name
Ali Mohammad Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2501
Email address
aalizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of 5-aminolevulinic acid on the treatment response and the quality of life in the patients with glioblastoma
Public title
Effects of 5-aminolevulinic acid on the quality of life in patients with glioblastoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with written informed consent; randomized; patients with glioblastoma multiforme; patients with KPS above 70 or ECOG 0-1; patients with 30-70 years
Exclusion criteria:
Exclusion criteria: Patients with renal, cardiac, and hepatic problems; Patients with intestinal obstruction; Patients with GFR less than 30; Patients with immunodeficiency such as AIDS and hepatitis; Patients with low white blood cell (less of 1000).
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups; the first group, the standard treatment with 5-ALA and the second group, the standard treatments without 5-ALA. The first group will receive 5-ALA 5 mg/kg, three hours before radiotherapy in all 30 sessions. In the second group, patients will receive just the standard treatments.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of Medical Sciences
Street address
Bulvar Keshavarz- Imam Khomaini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.115
Health conditions studied
1
Description of health condition studied
Glioblastoma multiforme
ICD-10 code
C71.9
ICD-10 code description
Malignant neoplasm of brain, unspecified
Primary outcomes
1
Description
Quality of life
Timepoint
At the beginning and end of the study
Method of measurement
The questionaries’
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The case group will receive the 5-ALA drug (5 mg/kg three hours before radiotherapy in all 30 sessions.
Category
Treatment - Drugs
2
Description
Control group: This group will just receive conventional treatments.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Research Center, Cancer Institute of IR. Iran, Imam Khomeini Hospital
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2798
Email
aalizadeh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2798
Email
aalizadeh@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2798
Email
aalizadeh@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Blvar Keshavarz - Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2798
Email
aalizadeh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Mohammad Alizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Blvar Keshavarz- Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2798
Email
aalizadeh@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available