Efficacy of Oncoxin-Viusid on the Reduction of Adverse Reactions to Chemotherapy and Radiotherapy in Patients Diagnosed with Cervical Cancer and Endometrial Adenocarcinoma — Oak Academic Publishing
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Efficacy of Oncoxin-Viusid on the Reduction of Adverse Reactions to Chemotherapy and Radiotherapy in Patients Diagnosed with Cervical Cancer and Endometrial Adenocarcinoma
Hospital “Ramón González Coro”, Havana, Cuba
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Hospital “Ramón González Coro”, Havana, Cuba
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Hospital “Ramón González Coro”, Havana, Cuba
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National Institute of Oncology and Radiobiology of Cuba, Havana, Cuba
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National Institute of Oncology and Radiobiology of Cuba, Havana, Cuba
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Laboratorios Catalysis S.L., Madrid, Spain
1 Hospital “Ramón González Coro”, Havana, Cuba
2 Hospital “Ramón González Coro”, Havana, Cuba
3 Hospital “Ramón González Coro”, Havana, Cuba
4 National Institute of Oncology and Radiobiology of Cuba, Havana, Cuba
5 National Institute of Oncology and Radiobiology of Cuba, Havana, Cuba
Introduction: Oncoxin-Viusid (OV) has shown antioxidant, immunomodulatory and anti-tumour capabilities in experimental studies on humans and animal subjects. Acute toxicity of Radiation Therapy (RT) and Chemotherapy (CT) in patients with cervical cancer and endometrial adenocarcinoma impact quality of life and, therefore, outcomes of these therapies. Objective: To identify Oncoxin-Viusid’s efficacy in reducing acute toxicity produced by onco-specific treatments in patients with cervical cancer and endometrial adenocarcinoma. Materials and Methods: A controlled, randomised double-blind phase II clinical trial was performed with a sample size of 63 patients distributed into 2 groups: one receiving the standard treatment plus the Oncoxin-Viusid nutritional supplement (OV group) and another receiving the standard treatment and placebo (P group). The primary efficacy variable is the proportion of secondary disruptions to acute adverse reactions produced by RT and CT. Results: The number of patients suffering adverse events from chemotherapy was 20.6% less in the OV group (70.0%) than in the placebo group (90.6%) ( p = 0.04). We recorded consistently normal values of haemoglobin ( - 6.2 OV group vs - 8.3 P group, p = 0.009), platelet count ( - 17.4 OV group vs - 27.6 P group, p = 0.009) and leukocytes ( - 31.8 OV group vs - 41.4 P group, p = 0.025) in the OV group, tolerating 4 more cytostatic doses on average than the placebo group. Significant increase in quality of life (QLQ-30) was registered in the OV group with a large effect size on such issues as emotional and social function (Cohen’s d = 0.9), as well as in the reduction of symptoms like dyspnea 60%, insomnia 15% and anorexia 30% (item CX-2), (Cohen’s d = 0.98), which were higher than the placebo group. Conclusions: OV administration reduces onco-specific adverse events and improves quality of life in patients diagnosed with cervical cancer and endometrial adenocarcinoma undergoing radiation therapy and chemotherapy.
Ferlay, J., Soerjomataram, I., Ervik, M., et al. (2014) Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 11.c.
Plummer, M., de Martel, C., Vignat, J., Ferlay, J., Bray, F. and Franceschi, S. (2016) Global Burden of Cancers Attributable to Infections in 2012: A Synthetic Analysis. The Lancet Global Health, 4, e609-e616. https://doi.org/10.1016/S2214-109X(16)30143-7
Anuario Estadístico de salud. Cuba 2017. http://www.sld.cu/servicios/estadisticas/
Catane, R. and Kloke, N.I.M. (2006) ESMO Handbook of Advanced Cancer Care. European Society for Medical Oncology Handbooks. London.
Rotman, M., Sedlis, A., Piedmonte, M.R., et al. (2006) A Phase III Randomized Trial of Postoperative Pelvic Irradiation in Stage IB Cervical Carcinoma with Poor Prognostic Features: Follow-Up of Gynecology Group Study. International Journal of Radiation Oncology, Biology, Physics, 65, 169-176. https://doi.org/10.1016/j.ijrobp.2005.10.019
Matsushima, H., Yonemura, K., Ohishi, K. and Hishida, A. (1998) The Role of Oxygen Free Radicals in Cisplatin-Induced Acute Renal Failure in Rats. Journal of Laboratory and Clinical Medicine, 131, 518-526. https://doi.org/10.1016/S0022-2143(98)90060-9
Pasupathi, P., Saravanan, G., Chinnaswamy, P. and Bakthavathsalam, G. (2009) Effect of Chronic Smoking on Lipid Peroxidation and Antioxidant Status in Gastric Carcinoma Patients. Indian Journal of Gastroenterology, 28, 65-67. https://doi.org/10.1007/s12664-009-0021-4
Gokul, S., Patil, V., Jailkhani, R., Hallikeri, K. and Kattappagari, K. (2010) Oxidant-Antioxidant Status in Blood and Tumor Tissue of Oral Squamous Cell Carcinoma Patients. Oral Diseases, 16, 29-33. https://doi.org/10.1111/j.1601-0825.2009.01598.x
Edward, H., Carlos, P. and Luther, B. (2008) Principles and Practice of Radiation Oncology. 5th Edition, Lippincott Williams & Wilkins, New York.
Gomez, E.V., Perez, Y.M., Sanchez, H.V., Forment, G.R., Soler, E.A., Bertot, L.C., et al. (2010) Antioxidant and Immunomodulatory Effects of Viusid in Patients with Chronic Hepatitis C. World Journal of Gastroenterology, 16, 2638-2647. https://doi.org/10.3748/wjg.v16.i21.2638
Khan, N., et al. (2008) Cancer Chemoprevention through Dietary Antioxidants: Progress and Promise. Antioxidants & Redox Signaling, 10, 475-510. https://doi.org/10.1089/ars.2007.1740
Lamson, D.W. and Brignall, M.S. (2001) Natural Agents in the Prevention of Cancer, Part Two: Preclinical Data and Chemoprevention for Common Cancers. Alternative Medicine Review, 6, 167-187.
Qiao, Y., Cao, J., Xie, L. and Shi, X. (2009) Cell Growth Inhibition and Gen Expression Regulation by (2)-Epigallocatechin-3-gallate in Human Cervical Cancer Cells. Archives of Pharmacal Research, 32, 1309-1315. https://doi.org/10.1007/s12272-009-1917-3
Yamamoto, T., Hsu, S., Lewis, J., Wataha, J., Dickinson, D., Singh, B., et al. (2003) Green Tea Polyphenol Causes Differential Oxidative Environments in Tumor versus Normal Epithelial Cells. Journal of Pharmacology and Experimental Therapeutics, 307, 230-236. https://doi.org/10.1124/jpet.103.054676
Mukhtar, H. and Ahmad, N. (1999) Green Tea in Chemoprevention of Cancer. Toxicological Sciences, 52, 111-117. https://doi.org/10.1093/toxsci/52.suppl_1.111
Bardia, A., Tleyjeh, I.M., Cerhan, J.R., Sood, A.K., Limburg, P.J., Erwin, P.J. and Montori, V.M. (2008) Efficacy of Antioxidant Supplementation in Reducing Primary Cancer Incidence and Mortality: Systematic Review and Meta-Analysis. Mayo Clinic Proceedings, 83, 23-34. https://doi.org/10.4065/83.1.23
Màrquez, J., Mena, J., Hernandez-Unzueta, I., Benedicto, A., Sanz, E., et al. (2016) Ocoxin Oral Solution Slows Down Tumor Growth in an Experimental Model of Colorectal Cancer Metastasis to the Liver in Balb/c Mice. Oncology Reports, 35, 1265-1272. https://doi.org/10.3892/or.2015.4486
Al-Mahtab, M., Akbar, S.M., Khan, M.S. and Rahman, S. (2015) Increased Survival of Patients with End-Stage Hepatocellular Carcinoma Due to Intake of Ocoxin, a Dietary Supplement. Indian Journal of Cancer, 52, 443-446. https://doi.org/10.4103/0019-509X.176699
Roomi, M.W., Ivanov, V., Kalinovsky, T., Niedzwiecki, A. and Rath, M. (2005) In Vivo Antitumor Effect of Ascorbic Acid, Lysine, Proline and Green Tea Extract on Human Colon Cancer Cell HCT 116 Xenografts in Nude Mice: Evaluation of Tumor Growth and Immunohistochemistry. Oncology Reports, 13, 421-425. https://doi.org/10.3892/or.13.3.421
Annabi, B., Currie, J.C., Moghrabi, A. and Béliveau, R. (2007) Inhibition of HuR and MMP-9 Expression in Macrophage-Differentiated HL-60 Myeloid Leukemia Cells by Green Tea Polyphenol EGCg. Leukemia Research, 31, 1277-1284. https://doi.org/10.1016/j.leukres.2006.10.001
Bentzen, S.M., Dorr, W., Anscher, M.S., Denham, J.W., Hauer-Jensen, M., et al. (2003) Normal Tissue Effects: Reporting and Analysis. Seminars in Radiation Oncology, 13, 189-202. https://doi.org/10.1016/S1053-4296(03)00036-5
Hernández-García, S., González, V., Sanz, E. and Pandiella, A. (2015) Effect of Oncoxin Oral Solution in HER2-Overexpressing Breast Cancer. Nutrition and Cancer, 67, 1159-1169. https://doi.org/10.1080/01635581.2015.1068819
Díaz-Rodríguez, E., Hernández-García, S., Sanz, E. and Pandiella, A. (2016) Antitumoral Effect of Ocoxin on Acute Myeloid Leukemia. Oncotarget, 7, 6231-6242. https://doi.org/10.18632/oncotarget.6862
Díaz-Rodríguez, E., El-Mallah, A.M., Sanz, E. and Pandiella, A. (2017) Antitumoral Effect of Ocoxin in Hepatocellular Carcinoma. Oncology Letters, 14, 1950-1958. https://doi.org/10.3892/ol.2017.6440
Díaz-Rodríguez, E., Sanz, E. and Pandiella, A. (2018) Antitumoral Effect of Ocoxin, a Natural Compound-Containing Nutritional Supplement, in Small Cell Lung. International Journal of Oncology, 53, 113-123.
Chon Rivas, I., Alert Silva, J., Alfonso, G., et al. (2018) Oncoxin-Viusid with Radiotherapy and Chemotherapy in Patients with Head and Neck Cancer: Results from a Phase II Randomised, Double-Blind Study. Journal of Cancer Science & Therapy, 10, 317-327. https://doi.org/10.4172/1948-5956.1000562
Hernandez, U.I., Benedicto, A., Olaso, E., et al. (2017) Ocoxin Oral Solution® as a Complement to Irinotecan Chemotherapy in the Metastatic Progression of Colorectal Cancer to the Liver. Oncology Letters, 13, 4002-4012.
Aaronson, N.K., Ahmedzai, S., Bergman, B., et al. (1993) The EORTC QLQ-C30. A Quality of Life Instrument for Use in International Clinical Trials in Oncology. Journal of the National Cancer Institute, 85, 365-375.
Greimel, E.R., Kuljanic Vlasic, K., Waldenstrom, A.C., Duric, V.M., Jensen, P.T., et al. (2006) The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Cervical Cancer Module: EORTC QLQ-CX24. Cancer, 107, 1812-1822. https://doi.org/10.1002/cncr.22217
Dugue, P.A., Rebolj, M., Garred, P. and Lynge, E. (2013) Immunosuppression and Risk of Cervical Cancer. Expert Review of Anticancer Therapy, 13, 20-42. https://doi.org/10.1586/era.12.159
Lamson, D.W. and Brignall, M.S. (2000) Antioxidants and Cancer Therapy II: Quick Reference Guide. Alternative Medicine Review, 5, 152-163.
Greimel, E., Thiel, I., Peintinger, F., Cegnar, I. and Pongratz, E. (2002) Prospective Assessment of Quality of Life of Female Cancer Patients. Gynecologic Oncology, 85, 140-147. https://doi.org/10.1006/gyno.2002.6586
Schwartzmann, L. (2003) Calidad de vida relacionada con la salud: Aspectos conceptuales. Ciencia y Enfermería, 9, 9-21. https://doi.org/10.4067/S0717-95532003000200002
Teresa, U.M., Concha, X. and Padilla, O. (2014) Calidad de vida en mujeres con cáncer cérvico uterino. Revista Chilena de Obstetricia y Ginecología, 79, 368-377. https://doi.org/10.4067/S0717-75262014000500003
Hsu, W., Chung, N., Chen, Y., Ting, L., Wang, P., Hsieh, P. and Chan, S. (2009) Comparison of Surgery or Radiotherapy on Complications and Quality of Life in Patients with the Stage IB and IIA Uterine Cervical Cancer. Gynecologic Oncology, 115, 41-45. https://doi.org/10.1016/j.ygyno.2009.06.028
Vaz, A., Marques, D., Costa, L., Siani, S., Barros, S. and Mendes, A. (2011) Quality of Life and Adverse Events after Radiotherapy in Gynecologic Cancer Survivors: A Cohort Study. Archives of Gynecology and Obstetrics, 284, 1523-1531. https://doi.org/10.1007/s00404-011-1886-x
Zeng, Y.C., Li, D. and Loke, A.Y. (2011) Life after Cervical Cancer: Quality of Life among. Nursing & Health Sciences, 13, 296-302. https://doi.org/10.1111/j.1442-2018.2011.00616.x