Objectives: Evaluation of the efficacy and safety of spinal-Z on patients with cancer of the upper part of the gastrointestinal tract.
Design: Prospective double blind clinical trial. The study population consist of 61 patients in 2 groups (Treatment and control).
Participants: Patients with cancer of the upper part of the gastrointestinal tract without concurrent diseases, metastasis and Abnormal liver and kidney function tests.
Intervention: Administration of 600 mg/m2 of oral Spinal-Z per day in the treatment group and placebo in the control group.
Main outcome: Quality of life, Demographic data, Length of cancer, Type of cancer, Family background, Abdominal pain, Burn heart, Constipation, Vomiting and Drug adverse effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612051165N15
Registration date:2017-03-01, 1395/12/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2010-04-11, 1389/01/22
Expected recruitment end date
2011-04-10, 1390/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of Spinal-Z on clinical symptom of the patients with cancer of the upper part of the gastrointestinal tract
Public title
Evaluation of the efficacy of Spinal-Z on patients with gastrointestinal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient with age of 25-75 year-old; Patients with gastric adenocarcinoma or Esophageal squamous cell carcinoma with standard treatment during the study; No sign of metastasis in the patients.
Exclusion criteria: Participate in the study with use of any other drugs; history of bone marrow or stem cells transplants; Comorbidities include active infection, respiratory failure, heart failure or left ventricular EF <50%, inflammatory disorders, including rheumatoid arthritis and gout false, thyroid disorders or a history of thyroid antibodies, hyperviscosity syndrome, osteoporosis, anemia, bone marrow disorders such as sickle cell form, thalassemia or myelodysplastic syndrome, immune deficiency and psychiatric diseases that decreases the patient's tolerance; Pregnancy or lactation; Serum creatinine more than 1.5 times the maximum amount of the normal range; AST and ALT more than 1.5 times the upper limit of normal; Alkaline phosphatase greater than 2.5 times the upper limit of the normal range; Bilirubin more than 1.5 mg/dl.
Age
From 25 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Molla sadra st., Sheikhbahaee St.,
City
Tehran
Postal code
Approval date
2010-02-21, 1388/12/02
Ethics committee reference number
IR.BMSU.REC.1388.2
Health conditions studied
1
Description of health condition studied
Gastrointestinal Cancer
ICD-10 code
C26.9
ICD-10 code description
Malignant neoplasm: Ill-defined sites within the digestive system
Primary outcomes
1
Description
Type of cancer
Timepoint
Before and after of intervention
Method of measurement
Examination and Diagnostic procedures
2
Description
Length of the cancer
Timepoint
During the study
Method of measurement
Examination and Diagnostic procedures
Secondary outcomes
1
Description
Pathology
Timepoint
Before and after of intervention
Method of measurement
Laboratory
2
Description
Drug Adverse effects
Timepoint
During the study
Method of measurement
History and physical examination
3
Description
Quality of life
Timepoint
Before and after of intervention
Method of measurement
Questionnaire
4
Description
Gastrointestinal signs: Abdominal pain, Heart burn, Constipation and vomiting
Timepoint
Before and after of intervention
Method of measurement
History and physical examination
Intervention groups
1
Description
In the treatment group administration of Spinal-Z to the treatment group in addition to the standard treatment.
Category
Treatment - Drugs
2
Description
In the control group administration of the placebo in addition of standard treatments
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences Hospital
Full name of responsible person
Dr. Yunes Panahi
Street address
Mollasadra St., Sheykhbahaee St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Street address
Mollasadra St., Sheykhbahaee St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Position
Critical care Pharmacotherapy, Professor
Other areas of specialty/work
Street address
Mollasadra St., Sheykhbahae St.
City
Tehran
Postal code
Phone
+98 21 8821 1524
Fax
Email
yunespanahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Position
Critical care Pharmacotherapy, Professor
Other areas of specialty/work
Street address
Molasadra St., Sheykhbahaee St.
City
Tehran
Postal code
Phone
+98 21 8821 1524
Fax
Email
yunespanahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)