Evaluation of the therapeutic effect of crocin along with standard regimes in colorectal cancer
Phase 3
Recruiting
- Conditions
- colorectal cancer.Malignant neoplasm of rectosigmoid junction
- Registration Number
- IRCT20131017015044N2
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Colorectal cancer patients with lung or liver metastasis or both that is measurable
Colorectal cancer patients who have not received any chemotherapy for metastasis
Exclusion Criteria
History of any allergy to saffron or its products
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival. Timepoint: One year after the treatment is completed. Method of measurement: Patient follow-up.
- Secondary Outcome Measures
Name Time Method Progression-free survival. Timepoint: During treatment and after it every 3 months. Method of measurement: criteria of Response evaluation criteria in solid tumors.;Anemia. Timepoint: Before each session of monthly chemotherapy. Method of measurement: laboratory assessment of complete blood count.;Neutropenia. Timepoint: Before each session of monthly chemotherapy. Method of measurement: laboratory assessment of complete blood count.;Thrombocytopenia. Timepoint: Before each session of monthly chemotherapy. Method of measurement: laboratory assessment of complete blood count.;Kidney function. Timepoint: Before each session of monthly chemotherapy. Method of measurement: laboratory assessment of BUN and creatinine.;Liver function. Timepoint: Before each session of monthly chemotherapy. Method of measurement: laboratory assessment of SGOT and SGPT.