Clinical trial · Interventional
Cholecalciferol(25-[OH]-Vitamin D) in Treating Patients With Colorectal Cancer
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
NCT01403103CI-TRIAL-00013504withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucinous Adenocarcinoma of the Colon | Colon Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Mucinous Adenocarcinoma of the Rectum | Rectal Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Signet Ring Adenocarcinoma of the Colon | — | UNRESOLVED | — |
| Signet Ring Adenocarcinoma of the Rectum | Rectal Signet Ring Cell Adenocarcinoma | ALIAS | 0.90 |
| Stage I Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemoprevention)
- description
- Patients receive cholecalciferol orally (PO) 7 days prior to scheduled surgery or endorectal ultrasound. Patients with sigmoid colon cancer or clinical stage I rectal cancer would proceed with surgical resection without preceding chemoradiation and will have a portion of normal colorectal mucosa and tumor tissue obtained for research purposes.
- interventionNames
- Dietary Supplement: cholecalciferol
- Procedure: biopsy
- Genetic: protein expression analysis
- Other: enzyme-linked immunosorbent assay
- Other: laboratory biomarker analysis
- Genetic: reverse transcriptase-polymerase chain reaction
Primary outcomes (2)
- measure
- Comparison of the expression of 15-PGDH mRNA and protein levels in tumor tissue
- timeFrame
- 7-14 days after treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a suspected diagnosis of adenocarcinoma of the rectum or sigmoid colon (e.g. based on appearance of mass or histology) referred to colorectal surgery who are expected to undergo routine proctosigmoidoscopy or flexible sigmoidoscopy in the surgeon's office as well as resection and/or endorectal ultrasound (EUS) as part of their routine care * The tumor must be accessible for biopsy and suitable for multiple biopsies * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Able to understand and willing to sign written informed consent document Exclusion Criteria: * Prior anti-cancer therapy for this cancer such as chemotherapy, biologic therapy, immune therapy or radiation therapy * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Unable to swallow capsules * Underlying condition that will interfere with absorption of orally ingested vitamin D, e.g., untreated fat malabsorption * History of allergic reaction to cholecalciferol or other vitamin D preparations * EXCLUSION CRITERIA FOR DOSING VITAMIN D: * Elevated ionized calcium * Primary hyperparathyroidism * Renal failure with estimated glomerular filtration rate \< 20 mL/min/1.73m\^2 as calculated using the Modification of Diet in Renal Disease (MDRD) study equation for the isotope dilution mass spectrometry (IDMS) - traceable creatinine methods reported by University Hospital Case Medical Center (UHCMC) laboratory (due to less active formation of 1,25 hydroxyvitamin D due to less hydroxylase) * Serum 25-OH-vitamin D \> 40 ng/ml
References
Publications (0)
Data not yet available
No reference posted for this study.