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Not yet recruitingNCT07867158BURSTUpdated Oct 9, 2026

Study of Boswellia for Urinary Toxicity in Prostate Cancer Radiotherapy

A Phase 2 interventional study of Boswellia serrata extract in Prostate Cancer, sponsored by Brigham and Women's Hospital. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Supportive care

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate cancer
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's planned enrollment of 20 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Boswellia

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

    Drug: Boswellia serrata extract

Interventions

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

    Also known as: Indian Frankincense

06

What researchers measure

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.

    Time frame: 1 week after initiation of oral Boswellia treatment.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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/ PubMed 31643176 ↗
  • 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. PubMed 31234670 ↗
  • 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. PubMed 25448323 ↗
  • 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. PubMed 16223251 ↗
  • 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. PubMed 34412175 ↗
  • 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. PubMed 41341032 ↗
  • 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. PubMed 35509480 ↗
  • 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. PubMed 28903409 ↗
  • 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. PubMed 19567671 ↗
  • 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. PubMed 18281494 ↗
  • 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. PubMed 12182991 ↗
  • 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. PubMed 15850917 ↗
  • 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. PubMed 10524406 ↗
  • 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. PubMed 27626365 ↗
  • 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. PubMed 21287538 ↗
  • 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. PubMed 22457547 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.

Of 569 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 84. This study's planned 6 months is below that.

Counting every sponsor, half of 666 studies reached it within 52 months; a quarter within 34 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2026
First posted
Oct 9, 2026
StartEst.
Oct 2026
Primary completionEst.
Apr 2027
CompletionEst.
Jun 2027
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07867158
Responsible party
Luke Peng (MD, Brigham and Women's Hospital) — Principal investigator
First posted
Oct 9, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 9, 2026

Study contacts

Riley Maddox
Contact
rmaddox@Bwh.harvard.edu
5084883898
Luke Peng, MD
Contact
lcpeng@bwh.harvard.edu
5084882000

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Indian frankincense

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