Comparison of the efficacy of Patoprazole, Metoclopramide, and Ondansetron in management of gastrointestinal symptoms in Thyroid cancer patients treated with I-131
Objectives: There are several therapeutic approaches in thyroid carcinoma. One of these treatments is Radioiodine therapy after total thyroidectomy. Because of high prevalence of gastrointestinal symptoms (50%) in patients treated with I-131 and lack of effective therapy for these symptoms, this study was designed.
Design: This study is a single blind clinical trial.
Settings and conducts: All patients eligible for radioiodine therapy (sample volume=85) will be divided into 4 groups randomly and each group will receive one of the drugs.
Participants: Inclusion criteria: 1- Patients affected by differentiated thyroid carcinoma, 2- All patients for whom total thyroidectomy is done.
Exclusion criteria: 1- Pregnant women, 2- Lactating women.
Intervention: 1- Metoclopramide Tab 10 mg 2 times daily 2- Pantoprazole Tab 20 mg 2 times daily 3- Ondansetron Tab 8 mg 2 times daily 4- Placebo (Starch Tab) 8 mg 2 times daily
Main outcome measure: After administration of I-131, during 3 days of staying in hospital the incidence and severity of nausea and the incidence of vomiting will be recorded and at the end of the study the effect of each drug in comparison to placebo in controlling the nausea and vomiting will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061713705N1
Registration date:2013-08-11, 1392/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Marjan Mirzababaee
Name of organization / entity
Taleqhani hospital/ Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2292 2992
Email address
m.mirzababaee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-04-08, 1391/01/20
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Patoprazole, Metoclopramide, and Ondansetron in management of gastrointestinal symptoms in Thyroid cancer patients treated with I-131
Public title
Comparison of the efficacy of 3 drugs in prevention of side effects of radioiodine therapy in thyroid cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- All the patients affected by differentiated thyroid carcinoma.
2- All the patients for whom total thyroidectomy is done.
Exclusion criteria:
1- Pregnant women
2- Lactating women
Age
From 15 years old to 78 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
85
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
Ethics committee of Shahid Beheshti University Of Medical Sciences
Street address
Aarabi street, Yaman street, Velanjak street
City
Tehran
Postal code
1985717443
Approval date
2012-10-28, 1391/08/07
Ethics committee reference number
124
Health conditions studied
1
Description of health condition studied
Thyroid carcinoma
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
Primary outcomes
1
Description
Nausea
Timepoint
Daily for 3 days
Method of measurement
Check list(Mild, Moderate, and severe)
2
Description
Vomiting
Timepoint
Daily for 3 days
Method of measurement
check list (has, or has not)
Secondary outcomes
empty
Intervention groups
1
Description
First group:
Metoclopramide, 10 mg, oral, 2 times daily, for 3 days
Category
Treatment - Drugs
2
Description
second group:
Pantoprazole, 20 mg, oral, 2 times daily, for 3 days
Category
Treatment - Drugs
3
Description
Third group;
Ondansetron, 8 mg, oral, 2 times daily, for 3 days
Category
Treatment - Drugs
4
Description
Forth group:
Placebo(Starch Tablet), 8 mg, oral, 2 times daily, for 3 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Taleqhani Hospital
Full name of responsible person
Dr. Marjan Mirzababaee
Street address
Aarabi street,Yaman street, Velanjak street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Dr. Mohammad Rahmati Roodsari
Street address
Aarabi street,Yaman street, Velanjak street
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
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
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Dr. Marjan Mirzababaee
Position
Nuclear Medicine Resident
Other areas of specialty/work
Street address
Aarabi street,Yaman street, Velanjak street
City
Tehran
Postal code
Phone
+98 21224326609
Fax
Email
m.mirzababaee@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Science
Full name of responsible person
Dr. Marjan Mirzababaee
Position
Nuclear Medicine Resident
Other areas of specialty/work
Street address
Aarabi street, Yaman street, Velanjak street
City
Tehran
Postal code
1985717433
Phone
+98 21224325609
Fax
Email
m.mirzababaee@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
Dr. Marjan Mirzababaee
Position
Nuclear Medicine Resident
Other areas of specialty/work
Street address
Aarbi street, Yaman street, Velenjak street
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 2560
Fax
Email
m.mirzababaee@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)