Ameliorative Potential of L-Alanyl L-Glutamine Dipeptide in Colon Cancer Patients Receiving Modified FOLFOX-6 Regarding the Incidence of Diarrhea, the Treatment Response, and Patients’ Survival: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Eligible Patients
2.2. Inclusion Criteria
2.3. Exclusion Criteria
2.4. Treatment Plan (Chemotherapy)
2.5. Follow Up
2.6. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Glutamine Group (n = 22) | Placebo Group (n = 22) | p-Value | ||
---|---|---|---|---|
Age (years) | Mean ± SD | 45.41 ± 5.72 | 53.09 ± 7.19 | <0.001 * |
Range | 35–61 | 44–66 | ||
Gender | Male | 7 (31.82%) | 10 (45.45%) | 0.390 |
Female | 15 (68.18%) | 12 (54.55%) | ||
ECOG performance status | 0 | 8 (36.36%) | 4 (18.18%) | 0.189 |
1 | 9 (40.91%) | 15 (68.18%) | ||
2 | 5 (22.73%) | 3 (13.64%) | ||
Site | Colon | 22 (100%) | 22 (100%) | - |
Pathology | Adenocarcinoma | 22 (100%) | 22 (100%) | - |
CEA | Mean ± SD | 3.54 ± 1.82 | 4.18 ± 2.06 | 0.284 |
Range | 1–9 | 1–9 | ||
Surgery | Yes | 22 (100%) | 22 (100%) | - |
Stage | Stage II | 5 (22.73%) | 8 (36.36%) | 0.322 |
Stage III | 17 (77.27%) | 14 (36.64%) | ||
Treatment | Chemotherapy | 22 (100%) | 22 (100%) | - |
Chemotherapy | mFOLFOX-6 | 22 (100%) | 22 (100%) | - |
Glutamine Group (n = 22) | Placebo Group (n = 22) | p-Value | |
---|---|---|---|
Partial response | 7 (31.82%) | 6 (27.27%) | 0.892 |
Complete response | 15 (68.18%) | 16 (72.73%) |
Glutamine Group (n = 22) | Placebo Group (n = 22) | p-Value | |
---|---|---|---|
After Two Cycles | |||
No diarrhea | 12 (54.55%) | 8 (36.36%) | 0.066 |
Grade 1 | 8 (36.36%) | 5 (22.73%) | |
Grade 2 | 2 (9.09%) | 7 (31.82%) | |
Grade 3 | 0 (0%) | 2 (9.09%) | |
After Four Cycles | |||
No diarrhea | 8 (36.36%) | 1 (4.55%) | < 0.001 * |
Grade 1 | 11 (50%) | 2 (9.09%) | |
Grade 2 | 2 (9.09%) | 11 (50%) | |
Grade 3 | 1 (4.55%) | 8 (36.36%) | |
After Six Cycles | |||
No diarrhea | 12 (54.55%) | 1 (4.55%) | < 0.001 * |
Grade 1 | 6 (27.27%) | 3 (13.6%) | |
Grade 2 | 4 (18.18%) | 9 (40.91%) | |
Grade 3 | 0 (0%) | 5 (22.73%) | |
Grade 4 | 0 (0%) | 4 (18.18%) |
Mean | SD | 95% CI for the Mean | Mortality | p-Value | |
---|---|---|---|---|---|
Glutamine group (n = 22) | 22.09 | 3.108 | 20.51–23.67 | 5 (22.7%) | 0.322 |
Placebo group (n = 22) | 20.73 | 2.986 | 18.21–23.25 | 8 (36.4%) |
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Sabry, N.M.; Naguib, T.M.; Kabel, A.M.; Khafagy, E.-S.; Arab, H.H.; Almorsy, W.A. Ameliorative Potential of L-Alanyl L-Glutamine Dipeptide in Colon Cancer Patients Receiving Modified FOLFOX-6 Regarding the Incidence of Diarrhea, the Treatment Response, and Patients’ Survival: A Randomized Controlled Trial. Medicina 2022, 58, 394. https://doi.org/10.3390/medicina58030394
Sabry NM, Naguib TM, Kabel AM, Khafagy E-S, Arab HH, Almorsy WA. Ameliorative Potential of L-Alanyl L-Glutamine Dipeptide in Colon Cancer Patients Receiving Modified FOLFOX-6 Regarding the Incidence of Diarrhea, the Treatment Response, and Patients’ Survival: A Randomized Controlled Trial. Medicina. 2022; 58(3):394. https://doi.org/10.3390/medicina58030394
Chicago/Turabian StyleSabry, Nesreen M., Tamer M. Naguib, Ahmed M. Kabel, El-Sayed Khafagy, Hany H. Arab, and Walid A. Almorsy. 2022. "Ameliorative Potential of L-Alanyl L-Glutamine Dipeptide in Colon Cancer Patients Receiving Modified FOLFOX-6 Regarding the Incidence of Diarrhea, the Treatment Response, and Patients’ Survival: A Randomized Controlled Trial" Medicina 58, no. 3: 394. https://doi.org/10.3390/medicina58030394