Study of Boswellia for Urinary Toxicity in Prostate Cancer Radiotherapy
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Boswellia serrata extract
DrugBoswellia 1500 mg three times per day, taken orally for up to 10 weeks
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: BoswelliaExperimental treatment 1 intervention
Trial outcomes
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: