The present study has been designed with the aim of investigation of the effects of Angiotensin Converting Enzyme Inhibitor (ACEI) on the Quality of Life of non-hospitalized patients with cancer cachexia. In a single-blinded randomized case controlled trial, 40 patients with gastric cancer in cancer cachexia aged 40-80 years old who referred to our clinics will been randomized into two groups. The patients will be randomized using a computer-based random digit generator based on the registration number of the patients (on the order of refer). In group A patients will been assigned to receive ACEI (Captopril) starting with 6.25 mg three times of day and increasing if tolerated to 12.5 mg two or three times of day and group B subjects will been served as controls and will been received placebo (starch pill). In order to obtain the values for the effect of ACEI on the quality of life of patients with Cancer Cachexia, they will been asked questions in order to fill out (quality of life) QLQ-C30 questionnaire 3 times; baseline, 1 and 2 months after first visit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050511375N3
Registration date:2014-10-23, 1393/08/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-23, 1393/08/01
Registrant information
Name
pouya farhadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1625 4206
Email address
farhadip@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sceinces
Expected recruitment start date
2013-10-01, 1392/07/09
Expected recruitment end date
2014-04-30, 1393/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Angiotensin Converting Enzyme Inhibitor on the Quality of Life of Non Hospitalized Patients With Cancer Cachexia
Public title
The Effect of Angiotensin Convetring Enzyme Inhibitor on the Quality of Life of Non Hospitalized Patients With Cancer Cachexia in Shiraz University Clinics
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with aged 40-80 years old; Patients with BMI less 18 and those with muscle wasting or only temporal wasting. Exclusion Criteria: Patients unable to continue the treatment; Patients with BMI more 18 without temporal or muscle wasting; Those with GFR less 50 ml/min; Positive history of other co-morbidity diseases; Patients with Hb less 9; Patients unavailable for or incapable of filling out questionnaires at different intervals.
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Shiraz University of Medical Sciences
Street address
Shiraz university of medical sciences Building - 7th floor - Zand Ave.
City
Shiraz
Postal code
Approval date
2013-09-15, 1392/06/24
Ethics committee reference number
CT-P-92-3059
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
C16.9
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Quality of life
Timepoint
Before and 1 month and 2 months after intervention
Method of measurement
QLQ-C30 questionnaire
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Bfore and 1 month and 2 months after intervention
Method of measurement
By BMI Formula
Intervention groups
1
Description
Intervention group will be administrated Captopril
Category
Treatment - Drugs
2
Description
Control group will be received placebo (starch pill)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Shiraz university of Medical Sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Midical Sciences
Full name of responsible person
Basir Hashemi
Street address
Shiraz university of medical sciences, Zand Ave
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 Midical 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mehdi Mirzaei
Position
Internist
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Phone
+98 71 1234 3529
Fax
Email
Mirzaeim@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Dehghani
Position
Hematologist
Other areas of specialty/work
Street address
Department of Internal Medicince, Nemazi hospital, Zand Ave
City
Shiraz
Postal code
Phone
+98 71 1627 9611
Fax
Email
dehghanim@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Pouya Farhadi
Position
General physician
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Phone
+98 71 1234 3529
Fax
Email
farhadip@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)