This pilot clinical trial studies cholecalciferol in treating patients with colorectal cancer. The use of cholecalciferol may slow disease progression in patients with colorectal cancer.
PRIMARY OBJECTIVES: I. To compare the expression of 15-hydroxyprostaglandin dehydrogenase (PGDH) messenger ribonucleic acid (mRNA) and protein levels in tumor tissue at baseline and after treatment with 25-hydroxy (OH)-vitamin D3 (cholecalciferol). II. To compare the expression of 15-PGDH mRNA and protein levels in normal colorectal mucosa at baseline and following treatment with 25-OH-vitamin D3. SECONDARY OBJECTIVES: I. To compare the expression of cyclooxygenase (COX)-1 and COX-2 mRNA in tumor tissues at baseline and after treatment with 25-OH-vitamin D3. II. To compare levels of prostaglandin E2 (PGE2) in tumor tissue at baseline and after treatment with 25-OH-vitamin D3. III. To compare the expression of COX-1 and COX-2 mRNA in normal colorectal mucosa at baseline and after treatment with 25-OH-vitamin D3. IV. To compare levels of PGE2 in normal colorectal mucosa at baseline and after treatment with 25-OH-vitamin D3. V. To evaluate the tolerability of a single 100,000 international unit (IU) dose of 25-OH-vitamin D3. OUTLINE: Patients receive cholecalciferol orally (PO) 7 days prior to scheduled surgery or endorectal ultrasound. Patients are only followed through surgery or endorectal ultrasound. In case of a vitamin-D-related toxicity, the patient will be followed for resolution of the toxicity, up to 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Given PO
Correlative studies
Correlative studies
Comparison of the expression of 15-PGDH mRNA and protein levels in tumor tissue
An increase in 15-PGDH expression will be defined as at least a 100% increase in mRNA by real-time reverse transcriptase (RT)-polymerase chain reaction (PCR) compared to baseline. Expression of 15-PGDH protein via ELISA in normal and tumor tissue at baseline and following treatment with vitamin D, as well as the absolute and fold changes will be summarized with descriptive statistics (e.g., mean, median, standard deviation, and interquartile range) and using box plots. In addition, 95% confidence intervals for the mean absolute and fold-changes in 15-PGDH levels will be calculated.
Time frame: 7-14 days after treatment
Comparison of the expression of 15-PGDH mRNA and protein levels in normal colorectal mucosa
An increase in 15-PGDH expression will be defined as at least a 100% increase in mRNA by real-time reverse transcriptase (RT)-polymerase chain reaction (PCR) compared to baseline. Expression of 15-PGDH protein via ELISA in normal and tumor tissue at baseline and following treatment with vitamin D, as well as the absolute and fold changes will be summarized with descriptive statistics (e.g., mean, median, standard deviation, and interquartile range) and using box plots. In addition, 95% confidence intervals for the mean absolute and fold-changes in 15-PGDH levels will be calculated.
Time frame: 7-14 days after treatment
Comparison of the expression of COX-1 and COX-2 mRNA in tumor tissues
Time frame: 7-14 days after treatment
Comparison of levels of PGE2 in tumor tissue
Time frame: 7-14 days after treatment
Comparison of the expression of COX-1 and COX-2 mRNA in normal colorectal mucosa
Time frame: 7-14 days after treatment
Comparison of levels of PGE2 in normal colorectal mucosa
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Correlative studies
Correlative studies
Correlative studies
Time frame: 7-14 days after treatment
Number of patients with grade 3 related toxicities of a single 100,000 IU dose of 25-OH-vitamin D3
Time frame: 18-25 days after treatment