Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs

Summary

To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.

Timeline

Start

2022-03-26

Primary completion

2024-03-31

Completion

2024-03-31

Publications

• Background Smit SG, Heyns CF. Management of radiation cystitis. Nat Rev Urol. 2010 Apr;7(4):206-14. doi: 10.1038/nrurol.2010.23. Epub 2010 Mar 9.
• Background Browne C, Davis NF, Mac Craith E, Lennon GM, Mulvin DW, Quinlan DM, Mc Vey GP, Galvin DJ. A Narrative Review on the Pathophysiology and Management for Radiation Cystitis. Adv Urol. 2015;2015:346812. doi: 10.1155/2015/346812. Epub 2015 Dec 22.
• Background Sandhu SS, Goldstraw M, Woodhouse CR. The management of haemorrhagic cystitis with sodium pentosan polysulphate. BJU Int. 2004 Oct;94(6):845-7. doi: 10.1111/j.1464-410X.2004.05044.x.
• Background Feldmeier JJ, Hampson NB. A systematic review of the literature reporting the application of hyperbaric oxygen prevention and treatment of delayed radiation injuries: an evidence based approach. Undersea Hyperb Med. 2002 Spring;29(1):4-30.
• Background Oscarsson N, Muller B, Rosen A, Lodding P, Molne J, Giglio D, Hjelle KM, Vaagbo G, Hyldegaard O, Vangedal M, Salling L, Kjellberg A, Lind F, Ettala O, Arola O, Seeman-Lodding H. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial. Lancet Oncol. 2019 Nov;20(11):1602-1614. doi: 10.1016/S1470-2045(19)30494-2. Epub 2019 Sep 16.
• Background Villeirs L, Tailly T, Ost P, Waterloos M, Decaestecker K, Fonteyne V, Van Praet C, Lumen N. Hyperbaric oxygen therapy for radiation cystitis after pelvic radiotherapy: Systematic review of the recent literature. Int J Urol. 2020 Feb;27(2):98-107. doi: 10.1111/iju.14130. Epub 2019 Oct 15.
• Background Lojanapiwat B, Sripralakrit S, Soonthornphan S, Wudhikarn S. Intravesicle formalin instillation with a modified technique for controlling haemorrhage secondary to radiation cystitis. Asian J Surg. 2002 Jul;25(3):232-5. doi: 10.1016/S1015-9584(09)60181-0.
• Background Westerman ME, Boorjian SA, Linder BJ. Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: A contemporary evaluation. Int Braz J Urol. 2016 Nov-Dec;42(6):1144-1149. doi: 10.1590/S1677-5538.IBJU.2015.0588.
• Background Comploj E, Pycha A, Trenti E, Palermo S, Bonatti M, Krause P, Folchini DM, Pycha A. Transarterial Embolization in the Management of Intractable Haemorrhage. Urol Int. 2021;105(1-2):95-99. doi: 10.1159/000511123. Epub 2020 Oct 16.
• Background Linder BJ, Tarrell RF, Boorjian SA. Cystectomy for refractory hemorrhagic cystitis: contemporary etiology, presentation and outcomes. J Urol. 2014 Dec;192(6):1687-92. doi: 10.1016/j.juro.2014.06.030. Epub 2014 Jun 14.
• Background Chlorophyll and Chlorophyllin Linus Pauling Institute Oregon State University. (Micronutrient Information)
• Background Egner PA, Wang JB, Zhu YR, Zhang BC, Wu Y, Zhang QN, Qian GS, Kuang SY, Gange SJ, Jacobson LP, Helzlsouer KJ, Bailey GS, Groopman JD, Kensler TW. Chlorophyllin intervention reduces aflatoxin-DNA adducts in individuals at high risk for liver cancer. Proc Natl Acad Sci U S A. 2001 Dec 4;98(25):14601-6. doi: 10.1073/pnas.251536898. Epub 2001 Nov 27.
• Background Citrin D, Cotrim AP, Hyodo F, Baum BJ, Krishna MC, Mitchell JB. Radioprotectors and mitigators of radiation-induced normal tissue injury. Oncologist. 2010;15(4):360-71. doi: 10.1634/theoncologist.2009-S104.
• Background Oriya A, Takahashi K, Inanami O, Miura T, Abe Y, Kuwabara M, Kashiwakura I. Individual differences in the radiosensitivity of hematopoietic progenitor cells detected in steady-state human peripheral blood. J Radiat Res. 2008 Mar;49(2):113-21. doi: 10.1269/jrr.07079. Epub 2007 Dec 12.
• Background Dainiak N. Hematologic consequences of exposure to ionizing radiation. Exp Hematol. 2002 Jun;30(6):513-28. doi: 10.1016/s0301-472x(02)00802-0.
• Background Jubert C, Mata J, Bench G, Dashwood R, Pereira C, Tracewell W, Turteltaub K, Williams D, Bailey G. Effects of chlorophyll and chlorophyllin on low-dose aflatoxin B(1) pharmacokinetics in human volunteers. Cancer Prev Res (Phila). 2009 Dec;2(12):1015-22. doi: 10.1158/1940-6207.CAPR-09-0099. Epub 2009 Dec 1.
• Background Nagini S, Palitti F, Natarajan AT. Chemopreventive potential of chlorophyllin: a review of the mechanisms of action and molecular targets. Nutr Cancer. 2015;67(2):203-11. doi: 10.1080/01635581.2015.990573. Epub 2015 Feb 4.
• Background Nahata MC, Slencsak CA, Kamp J. Effect of chlorophyllin on urinary odor in incontinent geriatric patients. Drug Intell Clin Pharm. 1983 Oct;17(10):732-4. doi: 10.1177/106002808301701006.
• Background Christiansen SB, Byel SR, Stromsted H, Stenderup JK, Eickhoff JH. [Can chlorophyll reduce fecal odor in colostomy patients?]. Ugeskr Laeger. 1989 Jul 3;151(27):1753-4. Danish.
• Background Yamazaki H, Fujieda M, Togashi M, Saito T, Preti G, Cashman JR, Kamataki T. Effects of the dietary supplements, activated charcoal and copper chlorophyllin, on urinary excretion of trimethylamine in Japanese trimethylaminuria patients. Life Sci. 2004 Apr 16;74(22):2739-47. doi: 10.1016/j.lfs.2003.10.022.
• Background WEINGARTEN M, PAYSON B. Deodorization of colostomies with chlorophyll. Rev Gastroenterol. 1951 Aug;18(8):602-4. No abstract available.
• Background BOWERS WF. Chlorophyll in wound healing and suppurative disease. Am J Surg. 1947 Jan;73(1):37-50. doi: 10.1016/0002-9610(47)90287-0. No abstract available.
• Background CARPENTER EB. Clinical experiences with chlorophyll preparations with particular reference to chronic osteomyelitis and chronic ulcers. Am J Surg. 1949 Feb;77(2):167-71. doi: 10.1016/0002-9610(49)90419-5. No abstract available.
• Background 2004 Physicians' Desk Reference. 58th ed. Stamford: Thomson Health Care, Inc.; 2003.
• Background Smith RG. Enzymatic debriding agents: an evaluation of the medical literature. Ostomy Wound Manage. 2008 Aug;54(8):16-34.
• Background Weir D, Farley KL. Relative delivery efficiency and convenience of spray and ointment formulations of papain/urea/chlorophyllin enzymatic wound therapies. J Wound Ostomy Continence Nurs. 2006 Sep-Oct;33(5):482-90. doi: 10.1097/00152192-200609000-00005.
• Background Aggarwal A, Shrivastava A, Kumar A, Ali A. Clinical and Epidemiological Features of SARS-CoV-2 Patients in SARI Ward of a Tertiary Care Centre in New Delhi. J Assoc Physicians India. 2020 Jul;68(7):19-26.
• Background Suryavanshi S, Sharma D, Checker R, Thoh M, Gota V, Sandur SK, Sainis KB. Amelioration of radiation-induced hematopoietic syndrome by an antioxidant chlorophyllin through increased stem cell activity and modulation of hematopoiesis. Free Radic Biol Med. 2015 Aug;85:56-70. doi: 10.1016/j.freeradbiomed.2015.04.007. Epub 2015 Apr 11.
• Background Sharma D, Kumar SS, Sainis KB. Antiapoptotic and immunomodulatory effects of chlorophyllin. Mol Immunol. 2007 Jan;44(4):347-59. doi: 10.1016/j.molimm.2006.02.031. Epub 2006 Apr 17.
• Background Warny M, Helby J, Nordestgaard BG, Birgens H, Bojesen SE. Lymphopenia and risk of infection and infection-related death in 98,344 individuals from a prospective Danish population-based study. PLoS Med. 2018 Nov 1;15(11):e1002685. doi: 10.1371/journal.pmed.1002685. eCollection 2018 Nov.
• Background Tan L, Wang Q, Zhang D, Ding J, Huang Q, Tang YQ, Wang Q, Miao H. Lymphopenia predicts disease severity of COVID-19: a descriptive and predictive study. Signal Transduct Target Ther. 2020 Mar 27;5(1):33. doi: 10.1038/s41392-020-0148-4. No abstract available.
• Background Zhang X, Tan Y, Ling Y, Lu G, Liu F, Yi Z, Jia X, Wu M, Shi B, Xu S, Chen J, Wang W, Chen B, Jiang L, Yu S, Lu J, Wang J, Xu M, Yuan Z, Zhang Q, Zhang X, Zhao G, Wang S, Chen S, Lu H. Viral and host factors related to the clinical outcome of COVID-19. Nature. 2020 Jul;583(7816):437-440. doi: 10.1038/s41586-020-2355-0. Epub 2020 May 20.
• Background Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.
• Background Interim Clinical Study Report (Project No. 0462-16) - An Open Label, Clinical Study To Assess Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Sodium Copper Chlorophyllin In Healthy Adult, Human Male Subjects.

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Indications