This study is conducted to evaluate the efficacy of olanzapine in symptom-relief and quality of life in gastric cancer patients. Study population is gastric cancer patients referring to cancer- treatment centers affiliated to Babol University of Medical Science, Northern Iran, whose disease is recently diagnosed and are candidate for chemotherapy. Inclusion criteria are diagnosis of gastric cancer in the patient and administration of chemotherapy protocol for the patient by related medical team. The patients with severe psychiatric disorders or receiving other antipsychotic drugs such as risperidone, clozapine, phenothiazine, ... in the last 30 days; the patients with severe neurologic diseases; mental retardation; abnormal laboratory tests in the serum level of creatinine, bilirubin, hepatic enzymes; neutrophil count; pregnancy; uncontrolled cardiac diseases in the last 6 months; and uncontrolled diabetes mellitus will be excluded. 30 eligible patients will be allocated randomly in the case and control groups. The intervention group will receive olanzapine (5-10 milligram per day) from a day before chemotherapy to 8 weeks after chemotherapy, besides the routine treatment which is implemented for the control group. The patients will be followed in 6 days after chemotherapy to assess adverse reactions and patients´ tolerance; also the appetite and other physical symptoms will be followed by phone calls and free doctor´s visit and medical interview- as necessary-. Finally, the patients will be followed at the 4th and 8th weeks after chemotherapy; treatment response, the status of depression and anxiety in the patients and the quality of life in the two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070822991N2
Registration date:2016-02-01, 1394/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of olanzapine on symptom- relief and quality of life in gastric cancer patients receiving chemotherapy
Public title
Effect of olanzapine in gastric cancer patients receiving chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gastric cancer patients whose disease diagnosed recently and candidate for chemotherapy; patient´s informed consent for participation in the study
Exclusion criteria: history of severe psychiatric problems such as severe cognitive disorders, psychotic disorders, antipsychotic medication such as risperidone, clozapine, phenothiazine,… in 30 days before or duration of the protocol; history of severe neurologic diseases such as metastasis to the brain, convulsion, ...; mental retardation; serum creatinine level more than 2 milligram per deciliter; total serum bilirubin level more than 2 milligram per deciliter; hepatic enzymes more than three times higher than upper limit of normal range; neutrophil count less than 1500; pregnancy; uncontrolled cardiac diseases such as cardiac arrhythmias, heart failure, acute myocardial infarction in the last 6 months; uncontrolled diabetes mellitus
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz Avenue, Babol
City
Babol
Postal code
4136747176
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
3480
Health conditions studied
1
Description of health condition studied
Neoplasms
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Quality of life
Timepoint
4th and 8th week after initiation of chemotherapy
Method of measurement
with standard questionnaire of WHO- QOL- BREF
2
Description
severity of depression and anxiety in the patient
Timepoint
4th and 8th weeks after chemotherapy
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
before treatment to six days after chemotherapy
Method of measurement
Rhodes index
Intervention groups
1
Description
Intervention group will receive 5-10 milligram per day olanzapine tablet from one day before chemotherapy to 8 weeks after chemotherapy, besides routine chemotherapy medication.
Category
Treatment - Drugs
2
Description
Control group will receive only routine chemotherapy medication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated to Babol University of Medical Sciences
Full name of responsible person
Novin Nikbakhsh, MD
Street address
Babol, Shahid Beheshti Hospital, Department of Surgery
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Grant name
معاونت تحقیقات و فن آوری دانشگاه علوم پزشکی و خدمات بهداشتی درمانی بابل
Grant code / Reference number
2097
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi, MD
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Department of Psychiatry, Shahid Yahyanejad Hospital, Babol
City
Babol
Postal code
4136747176
Phone
+98 11 3236 5683
Fax
+98 11 3219 0624
Email
sussanmo@hotmail.com
Web page address
mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Novin Nikbakhsh, MD
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
Department of Surgery, Shahid Beheshti Hospital, Babol
City
Babol
Postal code
4136747176
Phone
+98 11 3236 5683
Fax
+98 11 3219 0624
Email
novinsu@hotmail.com
Web page address
mubabol.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)