comparison of cabergolin with Sandostatin lar plus cabergolin in size reduction of nonfunctional pituitary adenomas after surgery :an open label clinical trial
In this Open label RCT study , efficacy of treatment with octreotide LAR plus cabergolin is compared with cabergulin only on tumor volume reduction and other symptom and sing of NFPA
Design
Two arm parallel groups randomized clinical trial with control
Settings and conduct
Patients with NFPA ,referral to endocrine clinic of Iran & Golestan university and undergo Transsphenoidal surgery , patients will be divided in two groups .Tumor size by measuring the adenoma diameter on MRI and visual field by kinetic perimetry (Goldmann perimetry), hormonal profile will be evaluated before treatment and 6 months after treatment. In the end of study , we will compare tumor size, visual field , hormonal profile before and after treatment between two groups.
Participants/Inclusion and exclusion criteria
In this study ,patients with NFPA ,in whom total tumor resection is less than 80% after surgery ,or tumor have been regrowth after surgery ,and their tumor is sstr positive in IHC staining for somatostatin receptor is included .
Intervention groups
15 patient will receive cabergolin 3 – 7 mg per week for 6 months.15 patient will receive sandostatin lar 20 mg q 28 day plus cabergolin 3 – 7 mg per week for 6 months.
Main outcome variables
Tumor volume reduction after surgery, visual field improvement ,pan hypopituitarism and requirement to resurgery
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20171003036521N2
Registration date:2018-03-12, 1396/12/21
Registration timing:prospective
Last update:2018-03-12, 1396/12/21
Update count:0
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
HAMIDEH AKBARI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5246
Email address
akbari.ha@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
IRAN UNIVERSITY OF MEDICAL SCIENCES INISTITUE OF ENDOCRIONOLOGY AND METABOLISEM
GOLESTAN UNIVERSITY OF MEDICAL SCIENCE
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of cabergolin with Sandostatin lar plus cabergolin in size reduction of nonfunctional pituitary adenomas after surgery :an open label clinical trial
Public title
comparison of cabergolin with Sandostatin lar plus cabergolin in treatment of nonfunctional pituitary adenomas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with NFPAs that don't cured by surgery and are SSR –R 1-5 positive ,who have less than 80% resection rate after surgery
Patient with NFPAs and are SSR –R 1-5 positive ,that patient who have tumor regrowth after surgery
Patient with NFPAs and are SSR –R 1-5 positive ,who previously didn't have received radiotherapy
Patient with NFPAs and are SSR –R 1-5 positive ,who previously didn't have received medical therapy with dopamine agonists or somatostatin analogues
Patient with NFPAs who don't , SSR –R 1-5 positive
Exclusion criteria:
Patients with NFPAs that have cured by surgery ,who have more than 80% resection rate after surgery
Patient with NFPAs and , who have emergency surgical indication
Patient with NFPAs , who previously have received radiotherapy
Patient with NFPAs who have emergency surgical indication
Patient with NFPAs ,who previously have received medical therapy with dopamine agonists or somatostatin analogues
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Random allocation is not applicable .Patients divided in two groups by physician .
Blinding (investigator's opinion)
Single blinded
Blinding description
In the study, participants (patients), don't know which group they have been allocated to, but physician know.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran - Hemmat Highway - next to Milad Tower - Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-10-10, 1396/07/18
Ethics committee reference number
IR.IUMS.REC1396.30249
Health conditions studied
1
Description of health condition studied
nonfunctional pituitary adenoma
ICD-10 code
D35.2
ICD-10 code description
Pituitary gland
Primary outcomes
1
Description
Non functional pituitary adenoma size
Timepoint
Non functional pituitary adenoma size before and 6 months after treatment
Method of measurement
Adenoma size in MRI
Secondary outcomes
1
Description
Secondary Hypothyroidism
Timepoint
Before and 3 , 6 months after treatment
Method of measurement
Measurement OF T3 ,T4, TSH , Blood sample
2
Description
Adrenal insufficiency
Timepoint
Before and 3 , 6 months after treatment
Method of measurement
Serum Cortisol level, blood sample
3
Description
Visual field
Timepoint
Before and 6 months after treatment
Method of measurement
Primetry
4
Description
Panhypopituitarism
Timepoint
Before and 3 , 6 months after treatment
Method of measurement
Pituitary hormonal assessment in blood sample
5
Description
Hypogonadism
Timepoint
Before and 3 , 6 months after treatment
Method of measurement
Measurement LH,FSH ,Esradiol in women and LH,FSH,Testosterone in men, Blood sample
Intervention groups
1
Description
Grupe 1 or intervention , will receive sandostatin lar 20 mg q 28 day plus cabergolin 3 – 7 mg per week for 6 months.Cabeergolin frome OSVE company and Sandostatin lar frome NOVARTIS company
Category
Treatment - Drugs
2
Description
Control group: Grupe 2 or control will receive cabergolin 3 – 7 mg per week for 6 months.Cabeergolin frome OSVE company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences ,Institute of Endocrinology and Metabolism
Full name of responsible person
Dr Mohammad Ebrahim Khamse
Street address
Number 10 , Firoozeh St ,Vali - asr Sq,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8894 5246
Fax
+98 21 8894 5173
Email
khamseh.m@iums.ac.ir
2
Recruitment center
Name of recruitment center
Golestan University of Medical Sciences ,Sayad Shirazi hospital , Gorgan ,
Full name of responsible person
Hamideh Akbari
Street address
Sayad shirazi bulvare , Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1417
Fax
+98 17 3221 1175
Email
akbari.ha@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Kazem Malakooti
Street address
Hemat Highway , Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
Research@iums.ac.ir
Grant name
Grant code / Reference number
30249
Is the source of funding the same sponsor organization/entity?