Multicomponent nutritional supplement Oncoxin and its influence on quality of life and therapy toxicity in patients receiving adjuvant chemotherapy

Dilyara Radikovna Kaidarova, Mikhail Valeryevich Kopp, Vadim S Pokrovsky, Maia Dzhugashvili, Zhanna Mukhataevna Akimzhanova, Ramil Zufarovich Abdrakhmanov, Elena Nikolaevna Babich, Evgeniy Viktorovich Bilan, Anton Valeryevich Byakhov, Sergey Nikolaevich Gurov, Irina Albertovna Koroleva, Anastasiia Sergeevna Mochalova, Svetlana Sergeevna Povaga, Maxim Vladimirovich Raigorodsky, Arthur Sidorovich Saifullin, Eduardo Sanz, Fedor Igorevich Petrovskiy, Dilyara Radikovna Kaidarova, Mikhail Valeryevich Kopp, Vadim S Pokrovsky, Maia Dzhugashvili, Zhanna Mukhataevna Akimzhanova, Ramil Zufarovich Abdrakhmanov, Elena Nikolaevna Babich, Evgeniy Viktorovich Bilan, Anton Valeryevich Byakhov, Sergey Nikolaevich Gurov, Irina Albertovna Koroleva, Anastasiia Sergeevna Mochalova, Svetlana Sergeevna Povaga, Maxim Vladimirovich Raigorodsky, Arthur Sidorovich Saifullin, Eduardo Sanz, Fedor Igorevich Petrovskiy

Abstract

Treatment of cancer often requires the use of adjuvant chemotherapy (ACT). In real clinical practice, numerous patients suffer from severe toxicity and reduced quality of life (QoL). Hence, there is a need to maintain QoL and to reduce therapy toxicity to comply with recommended chemotherapy (CT) regimens. The present study focused on the effects of the multi-component nutritional supplement Oncoxin (ONCX) on QoL and CT-induced toxicity in patients undergoing ACT. A total of 133 patients aged 50-70 years with gastric cancer IIB-IIIC or non-small cell lung cancer IIB-IIIA were enrolled in the present study: 84 received ONCX, and 49 were included in the control arm and received CT only. It was identified that after 2 weeks of treatment the patients receiving ONCX exhibited clinically meaningful improvement of QoL (measured by Edmonton Symptom Assessment System Questionnaire) compared with those in the control group (odds ratio, 2.07; 95% CI, 1.00-4.29). By the end of a 3 week-period, the albumin level was higher in patients of the ONCX group compared with those in the control group (mean, 38.1; 95% CI, 37.1-39.1 g/l; vs. mean, 35.5; 95% CI, 33.9-37.0; P=0.03; respectively). Furthermore, the use of ONCX substantively reduced the hepatic toxicity of ACT. The present prospective real clinical setting study revealed positive effects of ONCX on QoL and ACT toxicity. The present study was retrospectively registered under the study registration number NCT03550482 at ClinicalTrials.gov (June 8, 2018).

Keywords: Oncoxin; adjuvant chemotherapy; quality of life; therapy toxicity.

Copyright: © Kaidarova et al.

Figures

Figure 1.
Figure 1.
Disposition of patients.
Figure 2.
Figure 2.
Absolute changes from baseline (Visit 1) in (A) body mass and (B) serum albumin level. Visits 2 and 3 correspond to 2 and 3 weeks after the chemotherapy started, respectively. Rhombus are mean values and bars are lower and upper limits of 95% CI. *P

Figure 3.

Percentages of patients whose (A)…

Figure 3.

Percentages of patients whose (A) body mass and (B) serum albumin level remained…

Figure 3.
Percentages of patients whose (A) body mass and (B) serum albumin level remained unchanged or increased. Visits 2 and 3 correspond to 2 and 3 weeks after the chemotherapy started, respectively. *P

Figure 4.

Percentages of patients who had…

Figure 4.

Percentages of patients who had zero grade hepatic toxicity in ALT and AST…

Figure 4.
Percentages of patients who had zero grade hepatic toxicity in ALT and AST during the study visits. Visits 2 and 3 correspond to 2 and 3 weeks after the chemotherapy started, respectively. *P
Similar articles
Cited by
References
    1. Prasanna T, Beith J, Kao S, Boyer M, McNeil CM. Dose modifications in adjuvant chemotherapy for solid organ malignancies: A systematic review of clinical trials. Asia Pac J Clin Oncol. 2018;14:125–133. doi: 10.1111/ajco.12864. - DOI - PubMed
    1. Lakhanpal SH. Docetaxel and cyclophosphamide as adjuvant chemotherapy for early breast cancer: Primary prophylaxis with g-CSF is required. Breast Cancer Manage. 2013;2:367–374. doi: 10.2217/bmt.13.41. - DOI
    1. Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006;24:5381–5387. doi: 10.1200/JCO.2006.06.5391. - DOI - PubMed
    1. Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011;29:1465–1471. doi: 10.1200/JCO.2010.33.6297. - DOI - PubMed
    1. André T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350:2343–2351. doi: 10.1056/NEJMoa032709. - DOI - PubMed
Show all 29 references
Associated data
Related information
Full text links [x]
[x]
Cite
Copy Download .nbib
Format: AMA APA MLA NLM

NCBI Literature Resources

MeSH PMC Bookshelf Disclaimer

The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Unauthorized use of these marks is strictly prohibited.

Follow NCBI
Figure 3.
Figure 3.
Percentages of patients whose (A) body mass and (B) serum albumin level remained unchanged or increased. Visits 2 and 3 correspond to 2 and 3 weeks after the chemotherapy started, respectively. *P

Figure 4.

Percentages of patients who had…

Figure 4.

Percentages of patients who had zero grade hepatic toxicity in ALT and AST…

Figure 4.
Percentages of patients who had zero grade hepatic toxicity in ALT and AST during the study visits. Visits 2 and 3 correspond to 2 and 3 weeks after the chemotherapy started, respectively. *P
Similar articles
Cited by
References
    1. Prasanna T, Beith J, Kao S, Boyer M, McNeil CM. Dose modifications in adjuvant chemotherapy for solid organ malignancies: A systematic review of clinical trials. Asia Pac J Clin Oncol. 2018;14:125–133. doi: 10.1111/ajco.12864. - DOI - PubMed
    1. Lakhanpal SH. Docetaxel and cyclophosphamide as adjuvant chemotherapy for early breast cancer: Primary prophylaxis with g-CSF is required. Breast Cancer Manage. 2013;2:367–374. doi: 10.2217/bmt.13.41. - DOI
    1. Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006;24:5381–5387. doi: 10.1200/JCO.2006.06.5391. - DOI - PubMed
    1. Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011;29:1465–1471. doi: 10.1200/JCO.2010.33.6297. - DOI - PubMed
    1. André T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350:2343–2351. doi: 10.1056/NEJMoa032709. - DOI - PubMed
Show all 29 references
Associated data
Related information
Full text links [x]
[x]
Cite
Copy Download .nbib
Format: AMA APA MLA NLM
Figure 4.
Figure 4.
Percentages of patients who had zero grade hepatic toxicity in ALT and AST during the study visits. Visits 2 and 3 correspond to 2 and 3 weeks after the chemotherapy started, respectively. *P

References

    1. Prasanna T, Beith J, Kao S, Boyer M, McNeil CM. Dose modifications in adjuvant chemotherapy for solid organ malignancies: A systematic review of clinical trials. Asia Pac J Clin Oncol. 2018;14:125–133. doi: 10.1111/ajco.12864.
    1. Lakhanpal SH. Docetaxel and cyclophosphamide as adjuvant chemotherapy for early breast cancer: Primary prophylaxis with g-CSF is required. Breast Cancer Manage. 2013;2:367–374. doi: 10.2217/bmt.13.41.
    1. Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006;24:5381–5387. doi: 10.1200/JCO.2006.06.5391.
    1. Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011;29:1465–1471. doi: 10.1200/JCO.2010.33.6297.
    1. André T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350:2343–2351. doi: 10.1056/NEJMoa032709.
    1. Eichler M, Singer S, Janni W, Harbeck N, Rack B, Augustin D, Wischnik A, Kiechle M, Ettl J, Scholz C, et al. Pretreatment quality of life, performance status and their relation to treatment discontinuation and treatment changes in high-risk breast cancer patients receiving chemotherapy: Results from the prospective randomized ADEBAR trial. Breast Cancer. 2017;24:319–325. doi: 10.1007/s12282-016-0706-3.
    1. Yan Y, Mo Y, Zhang D. Magnesium isoglycyrrhizinate prevention of chemotherapy-induced liver damage during initial treatment of patients with gastrointestinal tumors. Zhonghua Gan Zang Bing Za Zhi. 2015;23:204–208. (In Chinese)
    1. Zhao H, Zhu W, Xie P, Li H, Zhang X, Sun X, Yu J, Xing L. A phase I study of concurrent chemotherapy and thoracic radiotherapy with oral epigallocatechin-3-gallate protection in patients with locally advanced stage III non-small-cell lung cancer. Radiother Oncol. 2014;110:132–136. doi: 10.1016/j.radonc.2013.10.014.
    1. Zhao H, Xie P, Li X, Zhu W, Sun X, Sun X, Chen X, Xing L, Yu J. A prospective phase II trial of EGCG in treatment of acute radiation-induced esophagitis for stage III lung cancer. Radiother Oncol. 2015;114:351–356. doi: 10.1016/j.radonc.2015.02.014.
    1. Al-Mahtab M, Akbar SM, Khan MS, Rahman S. Increased survival of patients with end-stage hepatocellular carcinoma due to intake of ONCOXIN(®), a dietary supplement. Indian J Cancer. 2015;52:443–446. doi: 10.4103/0019-509X.176699.
    1. Shumsky A, Bilan E, Sanz E, Petrovskiy F. Oncoxin nutritional supplement in the management of chemotherapy- and/or radiotherapy-associated oral mucositis. Mol Clin Oncol. 2019;10:463–468.
    1. Hui D, Shamieh O, Paiva CE, Khamash O, Perez-Cruz PE, Kwon JH, Muckaden MA, Park M, Arthur J, Bruera E. Minimal clinically important difference in the physical, emotional, and total symptom distress scores of the edmonton symptom assessment system. J Pain Symptom Manage. 2016;51:262–269. doi: 10.1016/j.jpainsymman.2015.10.004.
    1. Yagi T, Asakawa A, Ueda H, Ikeda S, Miyawaki S, Inui A. The role of zinc in the treatment of taste disorders. Recent Pat Food Nutr Agric. 2013;5:44–51. doi: 10.2174/2212798411305010007.
    1. Prasad AS. Impact of the discovery of human zinc deficiency on health. J Trace Elem Med Biol. 2014;28:357–363. doi: 10.1016/j.jtemb.2014.09.002.
    1. Sweeney JD, Ziegler P, Pruet C, Spaulding MB. Hyperzincuria and hypozincemia in patients treated with cisplatin. Cancer. 1989;63:2093–2095. doi: 10.1002/1097-0142(19890601)63:11<2093::AID-CNCR2820631104>;2-N.
    1. Ciubotariu D, Ghiciuc CM, Lupușoru CE. Zinc involvement in opioid addiction and analgesia-should zinc supplementation be recommended for opioid treated persons? Subst Abuse Treat Prev Policy. 2015;4:10–29.
    1. Weinstein SJ, Stolzenberg-Solomon R, Pietinen P, Taylor PR, Virtamo J, Albanes D. Dietary factors of one-carbon metabolism and prostate cancer risk. Am J Clin Nutr. 2006;84:929–935. doi: 10.1093/ajcn/84.4.929.
    1. Buijs N, Luttikhold J, Houdijk AP, van Leeuwen PA. The role of a disturbed arginine/NO metabolism in the onset of cancer cachexia: A working hypothesis. Curr Med Chem. 2012;19:5278–5286. doi: 10.2174/092986712803833290.
    1. Ham DJ, Murphy KT, Chee A, Lynch GS, Koopman R. Glycine administration attenuates skeletal muscle wasting in a mouse model of cancer cachexia. Clin Nutr. 2014;33:448–458. doi: 10.1016/j.clnu.2013.06.013.
    1. Grotz MR, Pape HC, van Griensven M, Stalp M, Rohde F, Bock D, Krettek C. Glycine reduces the inflammatory response and organ damage in a two-hit sepsis model in rats. Shock. 2001;16:116–121. doi: 10.1097/00024382-200116020-00006.
    1. Kantor ED, Lampe JW, Navarro SL, Song X, Milne GL, White E. Associations between glucosamine and chondroitin supplement use and biomarkers of systemic inflammation. J Altern Complement Med. 2014;20:479–485. doi: 10.1089/acm.2013.0323.
    1. Dominiak K, McKinney J, Heilbrun LK, Sarkar FH. Critical need for clinical trials: An example of a pilot human intervention trial of a mixture of natural agents protecting lymphocytes against TNF-alpha induced activation of NF-kappa B. Pharm Res. 2010;27:1061–1065. doi: 10.1007/s11095-010-0113-y.
    1. Khan R, Khan AQ, Lateef A, Rehman MU, Tahir M, Ali F, Hamiza OO, Sultana S. Glycyrrhizic acid suppresses the development of precancerous lesions via regulating the hyperproliferation, inflammation, angiogenesis and apoptosis in the colon of Wistar rats. PLoS One. 2013;8:e56020. doi: 10.1371/journal.pone.0056020.
    1. Prasad AS. Zinc: Mechanisms of host defense. J Nutr. 2007;137:1345–1349. doi: 10.1093/jn/137.5.1345.
    1. Fukagawa NK, Galbraith RA. Advancing age and other factors influencing the balance between amino acid requirements and toxicity. J Nutr 134 (6 Suppl) 2004:1569S–1574S.
    1. Miller GW, Lock EA, Schnellmann RG. Strychnine and glycine protect renal proximal tubules from various nephrotoxicants and act in the late phase of necrotic cell injury. Toxicol Appl Pharmacol. 1994;125:192–197. doi: 10.1006/taap.1994.1064.
    1. Zhong Z, Li X, Yamashina S, von Frankenberg M, Enomoto N, Ikejima K, Kolinsky M, Raleigh JA, Thurman RG. Cyclosporin a causes a hypermetabolic state and hypoxia in the liver: Prevention by dietary glycine. J Pharmacol Exp Ther. 2001;299:858–865.
    1. Mauriz JL, Matilla B, Culebras JM, Gonzalez P, Gonzalez-Gallego J. Dietary glycine inhibits activation of nuclear factor kappa B and prevents liver injury in hemorrhagic shock in the rat. Free Radic Biol Med. 2001;31:1236–1244. doi: 10.1016/S0891-5849(01)00716-X.
    1. Robbins D, Zhao Y. Manganese superoxide dismutase in cancer prevention. Antioxid Redox Signal. 2014;20:1628–1645. doi: 10.1089/ars.2013.5297.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera