Protocol summary

Summary
The average survival rate of patients with malignant brain gliomas(GBM) is about 6-11months and this study was designed to find a new way to treat these patients. Copper ion is essential cofactor of angiogenesis and its lead to proliferation of endothelial cells therefore copper depletion inhibits the angiogenic response induced by human brain tumor cells.The study population is patients with glioblastoma multiforme(GBM) aged between 18-65 years in both male and female sex in two intervention and control group and each one consisted of 25 patients.At treatment day,patients based on the main criteria included pathological diagnosis; tumor recurrence; age equal or greater than 18; KPS 60 or more and literacy are classified. in the intervention group, a low copper diet and penicillamine with initial dose of 250 mgr and increased to 1gr and in control group placebo at the same dose will be administered. For control of diet, both groups assess by food frequency questionnaire at the beginning, middle and end of the study. Drug and diet compliance also will be controlled by call. Serum copper concentration will be measured in the time of Baseline and after a month and a half (center study) and at the end of three months (end of study).As the primary outcome factors include VEGF, IL-6, IL-8 , TNF-α and KPS in both groups will be measured at the beginning and end of the study. To investigate the probable side effects of intervention, hemoglobin, WBC, platelet count, creatinine, bilirubin, liver function tests, PT and PTT measure in the beginning, middle and end of the study. Intervention period is considered for 3 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013101415018N1
Registration date: 2013-10-27, 1392/08/05
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-10-27, 1392/08/05
Registrant information
Name
Alirez Feli
Name of organization / entity
Tehran University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 42933050
Email address
dr_feli@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low copper diet and penicillamine combination on VEGF, IL-6, IL-8, TNFα and Karnovski performance score in high grade brain glioma after Gamma Knife Radiosurgery in Iran Gamma Knife Center
Public title
Effect of low copper diet and penicillamine combination on high grade brain glioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pathologic diagnosis; tumor recurrence; Age equal to or more than 18 years ;KPS equal to or more than 60 (the status of neurological function); informed consent;literacy Exclusion criteria: Avastin (Bevacizumab)use; reduction serum copper to less than 70 micrograms per deciliter;allergy to penicillin and penicillamine; pregnancy; Lack of adequate hematologic, hepatic and renal function
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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
Keshavarz Blvd,Ghods st.
City
Tehran
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
17241

Health conditions studied

1

Description of health condition studied
Brain tumor
ICD-10 code
C71.9,C72.
ICD-10 code description
Glioblastoma multiforme unspecified site

Primary outcomes

1

Description
Vascular endothelial growth factor
Timepoint
Before and after the intervention.
Method of measurement
How to measure: ELISA, scale: micro mEq per liter

2

Description
Interleukin-6
Timepoint
Before and after the intervention.
Method of measurement
How to measure: ELISA, scale: micro mEq per liter

3

Description
Interleukin-8
Timepoint
Before and after the intervention.
Method of measurement
How to measure: ELISA, scale: micro mEq per liter

4

Description
Tumor Necrosing Factor
Timepoint
Before and after the intervention.
Method of measurement
How to measure: ELISA, scale: micro mEq per liter

5

Description
Karnovski Performance Score(KPS)
Timepoint
Before intervention,one and a half months after the intervention and at the end of intervention.
Method of measurement
How to measure: clinical, scale:table

Secondary outcomes

1

Description
Drug complications
Timepoint
During the intervention
Method of measurement
Patient quote and physical exam

2

Description
serum copper
Timepoint
Before intervention,one and a half months after the intervention and at the end of intervention.
Method of measurement
How to measure: biochemical, scale: micro gram per deciliter.

Intervention groups

1

Description
Dietary and drug intervention for intervention group. Penicillamine capsule 250 mg every 6 hours, orally for 3 months. Low-copper diet according to table provided to patients for 3 months.
Category
Treatment - Drugs

2

Description
The control group received a placebo capsule of 250 mg orally every 6 hours for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Gamma Knife Center
Full name of responsible person
Alireza Feli
Street address
Dastgerdi martyr St., next to Hazrat Ali Asghar(AS) hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kamrani charity foundation,Iran Gamma Knife Center
Full name of responsible person
Mohsen Bakhtiari
Street address
Dastgerdi Martyr St., next to Hazrat Ali Asghar(AS) hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kamrani charity foundation,Iran Gamma Knife Center
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
University Research vice chancellor
Full name of responsible person
Mrs. Rostam abadi
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Research vice chancellor
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
Educational Vice Chancellor
Full name of responsible person
Dr.Mohammad javad Hossenzadeh
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Educational Vice Chancellor
Proportion provided by this source
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
Tehran University of Medical Sciences,School of Nutritional Sciences and Dietetics
Full name of responsible person
Alireza Feli
Position
General Physician
Other areas of specialty/work
Street address
Martyr Hemmat Highway, Next to Milad Hospital
City
Tehran
Postal code
Phone
+98 21 8670 4759
Fax
Email
dr_feli@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad javad Hosseinzadeh
Position
Nutritionist,Associate Professor
Other areas of specialty/work
Street address
Keshavarz Blvd, poursina st.
City
Tehran
Postal code
Phone
+98 21 4293 3050
Fax
Email
hosseinzadeh@sins.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Feli
Position
General Physician
Other areas of specialty/work
Street address
Martyr Hemmat Highway, Next to Milad Hospital, School of Nutritional Sciences and Dietetics
City
Tehran
Postal code
Phone
+98 21 2290 2514
Fax
+98 212902520
Email
dr_feli@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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