Mucinous Adenocarcinoma of the Rectum Clinical Trial
Official title:
Evaluation of the Effect of 25-OH-Vitamin D3 Therapy on 15-Prostaglandin Dehydrogenase Expression in Primary Tumor and Normal Colorectal Mucosa in Patients With Colorectal Cancer
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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