Metastatic bone pain palliation using cocktail of 177Lu/153Sm-EDTMP
Design
After obtaining consent from the patients, they will receive 177Lu/153Sm-EDTMP cocktail to relieve their pain. The number of patients will be 25, and they will be followed for 12 weeks after injection. Patients will be evaluated for pain and side effects every week and the pain score form will be filled for them. CBC testing will be performed weekly. At the end of three months, all patients will be evaluated on the effect of the drug and the amount of bone marrow suppression.
Settings and conduct
The project will be conducted at Namazai Hospital in Shiraz. Patients will be referred from the oncology department. A complete biography about matching the location of pain with the patient's bone scan, the amount and type of medication and ..., will be obtained from the patients and, if the requirements for palliative therapy are available, the patients will be registered for palliative care. All patients will be given an informed consent.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cancer patients with bone metastasis and with a positive bone scan according to pain location, maximally one month before treatment; Suitable CBC for at least one week before treatment; Normal liver and kidney function; Exit conditions: Inappropriate function of liver or kidney; WBC less than 1500; platelets less than 100000; hemoglobin less than 9; Spinal cord preesure; pathologic fractures; mismatch of pain site and bone involvement
Intervention groups
The 177Lu /153Sm-EDTMP cocktail is prepared from the Iran Atomic Energy Organization and 0.5 mCi/kg of each radioactive substance is injected for patients with bone metastases. The drug is administered as a single injection and patients will be followed up for 12 weeks (3 months).
Main outcome variables
The level of pain result from bone metastases
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180203038601N1
Registration date:2018-04-08, 1397/01/19
Registration timing:retrospective
Last update:2018-04-08, 1397/01/19
Update count:0
Registration date
2018-04-08, 1397/01/19
Registrant information
Name
Farnaz Khajeh-Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5320
Email address
khajehrahimi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
empty
Scientific title
Metastatic bone pain palliation using 177Lu/153Sm-EDTMP cocktail: a clinical trial
Public title
The effect of Lu-177-EDTMP-Sm-153 complex on bone pain palliation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cancerous patients with metastatic lesions in bone and with a positive bone scan coincident with pain location, maximally one month before treatment
Suitable CBC at least one week before treatment
Normal liver and kidney function
Exclusion criteria:
Inappropriate function of liver or kidney
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
25
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 Committee of Shiraz University of Medical Sciences
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2016-09-07, 1395/06/17
Ethics committee reference number
IR.SUMS.MED.REC.1395.18
Health conditions studied
1
Description of health condition studied
Pain caused by bone metastases
ICD-10 code
M89.8
ICD-10 code description
Other specified disorders of bone
Primary outcomes
1
Description
Pain caused by bone metastases
Timepoint
Every week for at least 12 weeks
Method of measurement
Completing the pain score form
Secondary outcomes
empty
Intervention groups
1
Description
The 177Lu /153Sm-EDTMP cocktail is prepared from the Iran Atomic Energy Organization and 0.5 mCi/ kg of each radioactive substance is injected for the patients with bone metastases who fill out informed consent form . The drug is administered as a single injection and patients will be followed up for 12 weeks (3 months). Patients are weekly evaluated for pain and side effects and pain score form will be filled for pain assessment. CBC test will be performed weekly to assess the most common side-effect that is bone marrow suppression. At the end of three months, all patients are evaluated for the effect of the drug and the amount of bone marrow suppression.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Mehr Sadat Alavi
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3612 5730
Email
khajehrahimi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehr Sadat Alavi
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3612 5720
Email
khajehrahimi@sums.ac.ir
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Mehr Sadat Alavi
Position
Scientific Member
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3612 5730
Email
alavimh@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehr Sadat Alavi
Position
Scientific Member
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3612 5730
Email
alavimh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farnaz Khejeh-Rahimi
Position
Nuclear medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Nuclear Medicine
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3612 5720
Email
khajehrahimi@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data is related to the thesis
When the data will become available and for how long
6 Months
To whom data/document is available
Supervisors and project partners
Under which criteria data/document could be used
after pressing the data
From where data/document is obtainable
Project manager
What processes are involved for a request to access data/document