The present study is evaluation of terapeutic effects of 177LU- EDTMP for metastatic bone pain palliation.
177Lu-EDTMP was prepared by IAEA with standard protocol .Thirty patients with confirmed bone metastasis by recent bone scan were referred to nuclear medicine ward. Renal function test, and baseline CBC were evaluated as exclusion criteria. Validated Persian version of Brief Pain Inventory short form (BPI-sf ) was used to evaluate the efficiency of intervention. 0.8 mCi/kg of body weight of Lu- EDTMP in form of sterile IV Injection was administered. Blood and urine sample were collected for dosimetric studies. Bone scan in first, third and seventh day after injection were done. Questionnaire were also been filled by same expert physician every two weeks while CBC and RFT were also been checked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109217611N1
Registration date:2014-03-20, 1392/12/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-20, 1392/12/29
Registrant information
Name
Mehrossadat Alavi
Name of organization / entity
Shiraz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5319
Email address
alavimh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Lu-177- HEDMP for bone pain palliation of bone metastasis in breast cancer
Public title
Clinical trial of Lu-177- HEDMP for bone pain palliation of bone metastasis in breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Severe metastatic bone pain in breast cancer; positive bone scan in recent 1 month corresponding to the painful regions ; normal recent CBC (WBC>2400/ul--Platelet>60000/UL)
Exclusion criteria: Negative bone scan ; Pathological fracture of the vertebrae ;
WBC<2400/ul---Platelet<60000/ul ; incooperative patients
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commetee of Shiraz university of Medical Sciences
Street address
4th flopor, vice chancellor of research-Shiraz University of Medical Sciences-Zand Street
City
Shiraz
Postal code
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
CT-P-92-2039
Health conditions studied
1
Description of health condition studied
BREAST CANCER
ICD-10 code
C50-C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
SEVERITY OF PAIN
Timepoint
every 2 weeks up to 12 weeks
Method of measurement
questionnaire-By call
Secondary outcomes
1
Description
reduced morbidity- reduce sedative consumption
Timepoint
12 weeks after drug administration
Method of measurement
questionnare
Intervention groups
1
Description
ُSingle dose slow IV injection of 0.8 mci/kg of Lu177 EDTMP and follow-up by questiunare and CBC measurement
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
nuclear medicine departement
Full name of responsible person
Mehrossadat Alavi
Street address
Nuclear Medicine Departement,Namazee Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
SeyyedBasir Hashemi
Street address
4th flopor, vice chancellor of research, Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Nuclear medicine departement, Shiraz University of Medical Sciences
Full name of responsible person
Mehrossadat Alavi
Position
Associate professor
Other areas of specialty/work
Street address
Nuclear Medicine Departement-Namazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1612 5319
Fax
Email
alavimh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nuclear Medicine Departement
Full name of responsible person
Mehrossadat Alavi
Position
Associate professor
Other areas of specialty/work
Street address
Nuclear Medicine Departement-Namazee Hospital
City
Shiraz
Postal code
Phone
+98 71 1612 5319
Fax
Email
alavimh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nuclear Medicine Departement, Shiraz university of Medical Sciences
Full name of responsible person
Mehrossadat Alavi
Position
Associate Professor
Other areas of specialty/work
Street address
Nuclear Medicine Departement-Namazee Hospital
City
Postal code
Phone
+98 71 1647 4835
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)