colorectal and gastric cancer. Malignant neoplasm of ill-defined sites within the digestive system
Conditions
Interventions
Intervention 1: Intervention group: One daily sublingual tablet of vitamin B12 in the amount of 500 micrograms along with 30 milligrams of saffron made in Mashhad Faculty of Pharmacy from the day befo
for 126 days. Intervention 2: Control group: One daily placebo sublingual tablet made in Mashhad Faculty of Pharmacy starting one day before oxaliplatin injection
for 126 days.
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Gastric or colorectal cancer for whom treatment with XELOX or mFOLFOX6 regimen will be started. Age between 18 to 70 years
Exclusion criteria
Exclusion criteria: Liver failure (ALT and AST serum level more than two to three times the normal level at the beginning of treatment) Renal failure (GFR<30 ml/min) Having a history of allergy to saffron or cyanocobalamin neuropathy history at the beginning of the study Having diabetes mellitus, pernicious anemia, chronic giardiasis, or malabsorption syndrome History of alcohol consumption, multivitamins containing B12, neuromodulator drugs such as anticonvulsants or calcium and magnesium Smoking (more than ten cigarettes a day) Patient dissatisfaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropathy occurrence rate. Timepoint: at the beginning of each chemotherapy course. Method of measurement: based on NCI-CTC (national cancer institute-common toxicity criteria version3).;Sensory and motor electrophysiological examinations. Timepoint: At the beginning and at the end of study. Method of measurement: Electromyography. | — |
Secondary
| Measure | Time frame |
|---|---|
| ALT serum level. Timepoint: at the beginning of the study, and 30, 60, 90 and 120 days after the beginning of the study. Method of measurement: Measurement of blood levels of ALT by the laboratory.;Serum creatinine levels. Timepoint: at the beginning of the study, and 30, 60, 90 and 120 days after the beginning of the study. Method of measurement: Serum creatinine level is measured by Jaffe method.;Serum of level AST. Timepoint: at the beginning of the study, and 30, 60, 90 and 120 days after the beginning of the study. Method of measurement: Measurement of blood levels of AST by the laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSepideh Elyasi
Mashhad University of Medical Sciences
Outcome results
None listed