Study of Boswellia for Urinary Toxicity in Prostate Cancer Radiotherapy

NCT07867158 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 547387
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Improvements in genitourinary (GU) toxicity from prostate radiation after the initiation of Boswellia as assessed by changes in patient reported outcomes

  The primary outcome endpoint will be the percentage of participants who experience improvement in urinary toxicity with Boswellia at the 1-week timepoint after a minimum of 2 days of treatment as determined by participants who mark "Improved" in response to the questionnaire item: "How have your urinary symptoms changed since starting Boswellia?" at the first weekly assessment.

  1 week after initiation of oral Boswellia treatment.

Study Arms (1)

Boswellia

EXPERIMENTAL

Boswellia 1500 mg three times per day, taken orally for up to 10 weeks

Drug: Boswellia serrata extract

Interventions

Boswellia serrata extract DRUG

Boswellia 1500 mg three times per day, taken orally for up to 10 weeks

Also known as: Indian Frankincense

Boswellia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically-proven prostate cancer undergoing fractionated radiation for prostate cancer.
• Patients must be developing worsening urinary symptoms from radiation as evaluated by treating physician.
• Fractionated radiation must be targeted at either the intact prostate or the prostate fossa (surgical bed) in cases of prior prostatectomy.
• Radiation fields may also include treatment of the pelvic lymph node basins and/or more distant targets including but not limited to nearby bone metastases and retroperitoneal lymph nodes.
• Brachytherapy boost prior or subsequent to external beam radiation course is allowed.
• Patients must have at least 1 week or more of scheduled radiation treatments remaining prior to enrollment in order to allow for data collection at the following week's routine on-treatment visit.
• Participants with a prior or concurrent malignancy or prior radiation are eligible for this trial.
• Age ≥18 years.
• Patients must be able to read and speak English or else be able to use interpreter services to communicate with providers and complete questionnaires.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants who are unable or unwilling to return for future visits to assess toxicity changes.
• Participants lacking the functional capacity required to report and describe their symptoms.
• Participants who are unable to swallow pills or have known allergy/adverse reaction to Boswellia.
• Participants with known moderate to severe liver disease.
• Participants taking medications which may interfere with the administration of Boswellia per the treating physician.
• Participants previously started on another agent for acute urinary toxicity (e.g. tamsulosin, ibuprofen, etc.) during the radiation course will be excluded. Additionally, Boswellia will be the only new agent started for urinary toxicity at the time of enrollment for the initial 1 week period. Future initiation of additional interventions and medications after the first week will be allowed.
• Participants for whom there is physician concern for interactions with patients' existing medications.
• Participants taking any of the following medications: clarithromycin, ketoconazole, ritonavir, itraconazole, nefazodone, indinavir, and saquinavir, carbamazepine, phenytoin, phenobarbital, rifampicin, St. John's wort

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Related Publications (16)

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  PMID: 31643176 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.

  PMID: 31234670 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.

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• 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.

  PMID: 16223251 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.

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• 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.

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• 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.

  PMID: 35509480 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.

  PMID: 28903409 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.

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• 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.

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• 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.

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• 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.

  PMID: 10524406 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.

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• 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.

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• 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.

  PMID: 22457547 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Frankincense

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Central Study Contacts

Riley Maddox

CONTACT

5084883898; rmaddox@Bwh.harvard.edu

Luke Peng, MD

CONTACT

5084882000; lcpeng@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share