Phase IIa Clinical Biomarker Trial of Dietary Arginine Restriction and Aspirin in Colorectal Cancer Patients
Abstract
:Simple Summary
Abstract
1. Introduction
2. Methods
2.1. Study Design
2.2. Eligibility Criteria
2.3. Intervention and On-Study Assessments
2.4. Clinical Evaluation
2.5. Statistical Analyses
2.6. Ethical Considerations & Data Monitoring
3. Results
3.1. Demographics
3.2. Dietary Analyses
3.3. Plasma Arginine, Plasma Ornithine Levels
3.4. Rectal Tissue Polyamine Analysis
3.5. Adverse Events
3.6. Quality of Life/Psychosocial Telephone Counseling (PTC) Intervention
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Total (n = 20) | ||
---|---|---|
Gender | Male | 13 (65%) |
Female | 7 (35%) | |
Mean Age | Male | 62.1 y (12.3) |
Female | 51.7 y (6.9) | |
Total | 58.1 y (11.6) | |
Race | Asian | 8 (40%) |
White | 12 (60%) | |
Ethnicity | Hispanic | 1 (5%) |
White | 19 (95%) | |
Tumor Subsite Location | Cecum | 1 (4.8%) |
Transverse | 1 (4.8%) | |
Sigmoid | 5 (23.8%) | |
Rectosigmoid | 4 (19%) | |
Rectum | 6 (28.6%) | |
Colorectum-NOS | 3 (15%) | |
AJCC Stage | I | 4 (19%) |
IIA | 4 (19%) | |
IIIA | 3 (14.3%) | |
IIIB | 8 (38.1%) | |
IIIC | 1 (4.8%) | |
Tumor Grade | Well-Differentiated (Gr 1) | 3 (15%) |
Moderately Differentiated (Gr 2) | 10 (50%) | |
Poorly Differentiated (Gr 3) | 1 (5%) | |
Missing | 6 (30%) | |
Odc Genotype | AA | 4 (20%) |
AG | 7 (35%) | |
GG | 9 (45%) | |
Randomized to PTC Intervention? | Yes No | 8 (40%) 7 (35%) |
N/A | 5 (25%) |
Variable | N | Mean | Median | Std Dev | Minimum | Maximum |
---|---|---|---|---|---|---|
Carbohydrate (g) Baseline Midpoint End of Study | 20 17 17 | 216.5 210.1 189.7 | 200.4 193.9 182.5 | 101.4 105.9 58.0 | 97.2 74.9 75.0 | 518.9 563.9 298.1 |
Fiber (g) Baseline Midpoint End of Study | 20 17 17 | 18.0 18.5 17.4 | 18.4 16.5 16.1 | 7.3 10.5 6.4 | 6.6 5.6 7.0 | 31.8 48.2 33.1 |
Fat (g) Baseline Midpoint End of Study | 20 17 17 | 56.5 51.4 49.2 | 49.8 52.4 48.2 | 29.6 32.9 19.0 | 16.7 17.6 14.8 | 160.4 154.6 79.8 |
Protein (g) Baseline Midpoint End of Study | 20 17 17 | 65.4 55.9 53.5 | 62.9 54.3 49.4 | 20.9 20.5 20.3 | 27.8 27.8 16.7 | 118.7 112.4 92.7 |
Energy (kcal) Baseline Midpoint End of Study | 20 17 17 | 1625.5 1515.7 1409.8 | 1595.1 1388.4 1445.1 | 682.2 766.7 401.9 | 661.4 630.0 508.4 | 3925.5 4090.4 2255.3 |
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Zell, J.A.; Taylor, T.H.; Albers, C.G.; Carmichael, J.C.; McLaren, C.E.; Wenzel, L.; Stamos, M.J. Phase IIa Clinical Biomarker Trial of Dietary Arginine Restriction and Aspirin in Colorectal Cancer Patients. Cancers 2023, 15, 2103. https://doi.org/10.3390/cancers15072103
Zell JA, Taylor TH, Albers CG, Carmichael JC, McLaren CE, Wenzel L, Stamos MJ. Phase IIa Clinical Biomarker Trial of Dietary Arginine Restriction and Aspirin in Colorectal Cancer Patients. Cancers. 2023; 15(7):2103. https://doi.org/10.3390/cancers15072103
Chicago/Turabian StyleZell, Jason A., Thomas H. Taylor, C. Gregory Albers, Joseph C. Carmichael, Christine E. McLaren, Lari Wenzel, and Michael J. Stamos. 2023. "Phase IIa Clinical Biomarker Trial of Dietary Arginine Restriction and Aspirin in Colorectal Cancer Patients" Cancers 15, no. 7: 2103. https://doi.org/10.3390/cancers15072103