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Evaluation of the efficacy of Spinal-Z on patients with gastrointestinal cancer

Phase 3
Conditions
Gastrointestinal Cancer.
Malignant neoplasm: Ill-defined sites within the digestive system
Registration Number
IRCT201612051165N15
Lead Sponsor
Baqiyatallah University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
61
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.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Type of cancer. Timepoint: Before and after of intervention. Method of measurement: Examination and Diagnostic procedures.;Length of the cancer. Timepoint: During the study. Method of measurement: Examination and Diagnostic procedures.
Secondary Outcome Measures
NameTimeMethod
Pathology. Timepoint: Before and after of intervention. Method of measurement: Laboratory.;Drug Adverse effects. Timepoint: During the study. Method of measurement: History and physical examination.;Quality of life. Timepoint: Before and after of intervention. Method of measurement: Questionnaire.;Gastrointestinal signs: Abdominal pain, Heart burn, Constipation and vomiting. Timepoint: Before and after of intervention. Method of measurement: History and physical examination.
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