(1) Radioactive Iodine is used as one of the effective treatments in thyroid cancer therapy and could damage other organs such as salivary glands in addition to its uptake in the target tissue.In order to decrease the dysfunction of salivary glands in patients treated with radioiodine many different methods have been applied and one of the most effective approaches in prevention and treatment of these complications is administration of salivary stimulant agents such as Pilocarpine.
(2)The purpose of this study is evaluating the effect of Pilocarpine on the absorbed dose and the side effect of salivary glands from radioiodine(3) in 20 patients at the initial phase among whom that are administering radioiodine in nuclear medicine department of Namazi hospital.
Patients must have no salivary gland disease, no history of uncontrolled asthma, no bronchospasm, no heart failure, no acute iritis and no close angle glaucoma.They will randomized in two intervention and control groups.
(4,5)Patients from intervention or control group will receive respectively Pilocarpine or Placebo every 8 hours, start at 2 hours after administration of radioiodine. All groups will have scintigraphy at 2, 5, 13, 24 and 48 hours after administering I-131. Subjective symptoms such as mouth dryness, sialadenitis and pain in salivary glands will be checked up to 3 months.
(6)At last the effect of administering Pilocarpine on radioiodine absorbed dose and the levels of radioiodine therapy side effects will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060917684N3
Registration date:2014-11-10, 1393/08/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-10, 1393/08/19
Registrant information
Name
Mahdi Haghighatafshar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4835
Email address
afsharm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical science, Vice chancellor for research
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of using oral pilocarpine on absorbed salivary gland dose and side effects in patients on radioiodine therapy
Public title
The effect of Pilocarpine on absorbed salivary gland dose in patients on radioiodine therapy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with diagnosis of hyperthyroidism or thyroid cancer who are candidate for radioiodine therapy
Exclusion criteria: patient with history of uncontrolled asthma; bronchospasm; severe COPD; heart failure; acute iritis; close angle glaucoma; pateint use antihypertensive drugs; history of salivary gland disease; no patient consent.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical science, Ethics Committee
Street address
Central building of Shiraz University of Medical Science, Karimkhan-e Zand Boulevard
City
Shiraz
Postal code
14336 - 71348
Approval date
2014-05-20, 1393/02/30
Ethics committee reference number
CT-P-9366-6246
Health conditions studied
1
Description of health condition studied
Thyroid Cancer therapy with I-131
ICD-10 code
C73-C75
ICD-10 code description
Malignant neoplasms of thyroid and other endocrine glands
Primary outcomes
1
Description
Organ dose per administered I131 Activity (ODPA)
Timepoint
1,2,3,4,5,13,25,48 h after receiving radio-iodine 131
Method of measurement
By scintigraphy and MIRD Schema software calculations
Secondary outcomes
1
Description
Side effects of radio-Iodine 131
Timepoint
Every 4-6 weeks
Method of measurement
Asking the patient
Intervention groups
1
Description
Intervention group:Using oral Pilocarpine every 8 hours, start at 2 hours after administration of radioiodine.
Category
Prevention
2
Description
Control group:Using oral Placebo every 8 hours, start at 2 hours after administration of radioiodine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Namazi Hospital
Full name of responsible person
Nuclear medicine and molecular imaging research center
Street address
nuclear medicine department, Namazi hospital, Namazi Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical science, Vice chancellor for research
Full name of responsible person
Zahra Pandkhahi
Street address
Central building of Shiraz University of Medical Science, Karimkhan-e Zand Boulevard
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 science, Vice chancellor for research
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
Shiraz university of medical science
Full name of responsible person
Nuclear medicine and molecular imaging research center
Position
Expert of the center
Other areas of specialty/work
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Postal code
11351-71937
Phone
+98 71 1612 5330
Fax
Email
nmmirc@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Nuclear medicine and molecular imaging research center
Position
Nuclear medicine Specialist
Other areas of specialty/work
Street address
Nuclear Medicine department, Namazi Hospital, Namazi Square
City
Shiraz
Postal code
11351-71937
Phone
+98 71 1612 5330
Fax
Email
nmmirc@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)