Study of Boswellia for Urinary Toxicity in Prostate Cancer Radiotherapy

Summary

The goal of this clinical trial is to determine whether Boswellia serrata extract is effective at reducing urinary symptoms in patients undergoing radiation for prostate cancer. The main question it aims to answer is whether patients taking Boswellia report significantly improved urinary symptoms at the 1-week timepoint after taking a minimum of two (2) days of Boswellia treatment. Participants will follow a treatment plan of 1500 mg of oral Boswellia, taken three times per day, and will report their symptoms and side effects using a specialized questionnaire.

Timeline

Start

2026-10

Primary completion

2027-04

Completion

2027-06

Publications

• Background LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547852/
• Background Alluri VK, Dodda S, Kilari EK, Golakoti T, Sengupta K. Toxicological Assessment of a Standardized Boswellia serrata Gum Resin Extract. Int J Toxicol. 2019 Sep/Oct;38(5):423-435. doi: 10.1177/1091581819858069. Epub 2019 Jun 24.
• Background Shang Y, Cui D, Yi S. Opening tight junctions may be key to opening the blood-prostate barrier. Med Sci Monit. 2014 Dec 2;20:2504-7. doi: 10.12659/MSM.890902.
• Background Reising K, Meins J, Bastian B, Eckert G, Mueller WE, Schubert-Zsilavecz M, Abdel-Tawab M. Determination of boswellic acids in brain and plasma by high-performance liquid chromatography/tandem mass spectrometry. Anal Chem. 2005 Oct 15;77(20):6640-5. doi: 10.1021/ac0506478.
• Background Kulkarni PD, Damle ND, Hingorani L, Bhaskar VH, Ghante MR, Patil A, Gurjar M, Gota V. Pharmacokinetics of solid lipid Boswellia serrata particles in healthy subjects. Drug Metab Pers Ther. 2021 Apr 5;36(3):215-221. doi: 10.1515/dmpt-2020-0176.
• Background Peng C, Yang Y, Wang Y, Gong B, Sun X, Yang X. From bench to bedside, boswellic acids in anti-inflammatory therapy - mechanistic insights, bioavailability challenges, and optimization approaches. Front Pharmacol. 2025 Nov 18;16:1692443. doi: 10.3389/fphar.2025.1692443. eCollection 2025.
• Background Presicce F, Barrese F, Cantiani A, Filianoti A, Tuzzolo D, Di Palma P, Lauretti S, Brunori S, Martini M. Boswellia resin extract and propolis derived polyphenols in patients with type III chronic prostatitis/chronic pelvic pain syndrome: An Italian prospective multicenter study. Asian J Urol. 2022 Apr;9(2):139-145. doi: 10.1016/j.ajur.2021.09.002. Epub 2021 Sep 11.
• Background Schmidt C, Loos C, Jin L, Schmiech M, Schmidt CQ, Gaafary ME, Syrovets T, Simmet T. Acetyl-lupeolic acid inhibits Akt signaling and induces apoptosis in chemoresistant prostate cancer cells in vitro and in vivo. Oncotarget. 2017 Jul 8;8(33):55147-55161. doi: 10.18632/oncotarget.19101. eCollection 2017 Aug 15.
• Background Pang X, Yi Z, Zhang X, Sung B, Qu W, Lian X, Aggarwal BB, Liu M. Acetyl-11-keto-beta-boswellic acid inhibits prostate tumor growth by suppressing vascular endothelial growth factor receptor 2-mediated angiogenesis. Cancer Res. 2009 Jul 15;69(14):5893-900. doi: 10.1158/0008-5472.CAN-09-0755. Epub 2009 Jun 30.
• Background Lu M, Xia L, Hua H, Jing Y. Acetyl-keto-beta-boswellic acid induces apoptosis through a death receptor 5-mediated pathway in prostate cancer cells. Cancer Res. 2008 Feb 15;68(4):1180-6. doi: 10.1158/0008-5472.CAN-07-2978.
• Background Coleman CN, Kelly L, Riese Daly N, Beard C, Kaplan I, Lamb C, Propert K, Manola J. Phase III study of ibuprofen versus placebo for radiation-induced genitourinary side effects. Int J Radiat Oncol Biol Phys. 2002 Sep 1;54(1):191-4. doi: 10.1016/s0360-3016(02)02907-3.
• Background Elshaikh MA, Ulchaker JC, Reddy CA, Angermeier KW, Klein EA, Chehade N, Altman A, Ciezki JP. Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final report of a double-blind placebo-controlled randomized study. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):164-9. doi: 10.1016/j.ijrobp.2004.09.036.
• Background Prosnitz RG, Schneider L, Manola J, Rocha S, Loffredo M, Lopes L, D'Amico AV. Tamsulosin palliates radiation-induced urethritis in patients with prostate cancer: results of a pilot study. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):563-6. doi: 10.1016/s0360-3016(99)00246-1.
• Background Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14.
• Background Kirste S, Treier M, Wehrle SJ, Becker G, Abdel-Tawab M, Gerbeth K, Hug MJ, Lubrich B, Grosu AL, Momm F. Boswellia serrata acts on cerebral edema in patients irradiated for brain tumors: a prospective, randomized, placebo-controlled, double-blind pilot trial. Cancer. 2011 Aug 15;117(16):3788-95. doi: 10.1002/cncr.25945. Epub 2011 Feb 1.
• Background Siddiqui MZ. Boswellia serrata, a potential antiinflammatory agent: an overview. Indian J Pharm Sci. 2011 May;73(3):255-61. doi: 10.4103/0250-474X.93507.

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