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Study of extremely low frequency electromagnetic effect on bladder tumor response with stage II, III, IV and status of T2 - T3A to chemo radiotherapy

Protocol summary

Summary
Objectives: The aim of this study is to use electromagnetic waves along with chemo radiotherapy treatment to increase the permeability of tumor cells to chemical drugs In order to increase the efficiency of drug for destroying tumor and also enhance the output of treatment. On the other hand this measure reduce the time of treatment duration and side effects of treatment factors. Design: The type of this research was determined to be case- study (interventional). In this study chemo radiotherapy method plus electromagnetic waves with very low frequency (1Hz) will be used for treating bladder cancer. Setting and conduct: After each stage of chemotherapy, patients are exposed to repetitive trans cranial magnetic stimulation device (RTMS) for 30 seconds and receive 30 pulses 1 Hz. These pulses caused the cell's pores be opened and drugs permeate into the tumor cells easily to destroy them. Inclusion criteria: Patients with bladder cancer in grades 2, 3, 4 and stage T2 to T3A, without cystectomy, patients with heart and respiratory problem and etc that are not candidate to be surgically operated or patients who want to maintain their bladder. Exclusion criteria: Patients are in stages T1 and T4, patients with creatinine > 1.5, patients don't have proper physical ability clinically (performance status>2) and patients with severe leukopenia or with lack of therapy tolerance. Intervention: Electromagnetic waves, chemo radiotherapy Main outcome measures (variables): Tumor grade, drug dose, radiation dose, old, sex.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013011312124N1
Registration date: 2013-04-21, 1392/02/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-21, 1392/02/01
Registrant information
Name
Sadegh Dehghani
Name of organization / entity
Shahid Beheshti medical sciences univesity
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 5814
Email address
s.dehghani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Cancer Research Center of Shahid Beheshti University of Medical Sciences Urology Nephrology Research Center of Shahid Beheshti University of Medical Sciences Vice chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-02-18, 1391/11/30
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of extremely low frequency electromagnetic effect on bladder tumor response with stage II, III, IV and status of T2 - T3A to chemo radiotherapy
Public title
The use of very low frequency electromagnetic waves with radiotherapy and chemotherapy for treating bladder tumors.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with bladder cancer; Patients without cholecystectomy; Patients with heart, lung problem and... are not candidates for surgery; Patients who are in grades 2, 3, 4 and stage T2 to T3A. Exclusion criteria: Createnine> 1.5; Patients don't have physical ability clinically (performance status>2 ); Patients who are in stage T1 and T4; Patients because of sever leukopenia cannot tolerance the treatment.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics committee of Shahid Beheshti university of medical sciences
Street address
N#44, Next of Labbafinejad Hospital, 9th st Boostan, Pasdaran ave
City
Tehran
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
1225/پ/1

Health conditions studied

1

Description of health condition studied
Bladder cancer
ICD-10 code
C67.0, C67
ICD-10 code description
Trigone of bladder, Dome of bladder, Lateral wall of bladder, Anterior wall of bladder, Posterior wall of bladder, Bladder neck, Ureteric orifice, Urachus, Overlapping lesion of bladder, Bladder, unspecifie

Primary outcomes

1

Description
Tumor grade
Timepoint
Before of treatment
Method of measurement
Ultrasond, CT, MR, Cystectomy

2

Description
Drug dose
Timepoint
Before of treatment and during of treatment
Method of measurement
According to grade and stage of tumor

3

Description
Radiation dose
Timepoint
Before of treatment and during of treatment
Method of measurement
According to grade and stage of tumor

4

Description
Old
Timepoint
Before of treatment
Method of measurement
Patient's record or interview

5

Description
Sex
Timepoint
Before of treatment
Method of measurement
Patient's record or interview

Secondary outcomes

1

Description
Treatment side effects
Timepoint
Along of treatment
Method of measurement
Visual and blood test

2

Description
BUN, Crea, SGOT, SGPT
Timepoint
before treatment and along of treatment
Method of measurement
blood test

3

Description
Blood cells count
Timepoint
Before treatment and along of treatment
Method of measurement
Blood test

4

Description
Tumor size
Timepoint
Before treatment and middle of treatment and end of treatment
Method of measurement
Ultrasond, CT, MRI, Cystectomy

Intervention groups

1

Description
The use of RTMS device for generating electromagnetic waves with frequency 1HZ in the intervention group
Category
Treatment - Other

2

Description
The use of RTMS device while it is turn off in control group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Radiotherapy department of Shohada Tajrish hospital
Full name of responsible person
Dr Bahram Mofid
Street address
Shohada Tajrish Hospital, Tajrish
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cancer Research Center of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Esmaeil Akbari
Street address
Cancer Research Center of Shahid Beheshti University of Medical Sciences, Shohadaye Tajrrish Hospital, Tajrish Sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cancer Research Center of Shahid Beheshti University of Medical Sciences
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
Urology Nefrology Research Center of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Naser Shakhse Salim
Street address
N#44, Next of Labbafinejad Hospital, 9th st Boostan, Pasdaran ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Nefrology Research Center of Shahid Beheshti University of Medical Sciences
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
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Doctor Mohammad Rahmati Roodsari
Street address
Shahid Beheshti University of Medical Sciences, Next of Taleghani Hospital, Parvaneh st, Yaman st, Shahid Chamran Highway
City
Tehran
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, Shahid Beheshti University of Medical Sciences
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
Urology Nephrology Research Center
Full name of responsible person
Doctor Bahram Mofid
Position
Oncologist
Other areas of specialty/work
Street address
Radiotherapy Department, Shohada Tajrish Hospital, Tajrish
City
Tehran
Postal code
Phone
+98 21 2271 8081
Fax
Email
mofid429@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadegh Dehghani
Position
M.Sc in Radiobiology
Other areas of specialty/work
Street address
Dorm N. 21, Shahid Ghazvini Alley, North Felestin St, Vali Asr Sqr
City
Tehran
Postal code
Phone
+98 21 8898 5814
Fax
Email
dehghan907@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadegh Dehghani
Position
M.Sc.in Radiobiology
Other areas of specialty/work
Street address
Dorm N. 21, Shahid Ghazvini Alley, North Felestin St, Vali Asr Sqr
City
Tehran
Postal code
Phone
+98 21 8898 5814
Fax
Email
dehghan907@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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