Superficial Bladder CancerPhase 1/2BaobabNCT01939756
Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms
A Phase 1/2 study testing Intravesical baobab oil in people with Superficial Bladder Cancer and Lower Urinary Tract Symptoms, run by Savino M. Di Stasi at 2 sites in Italy.
Trial summary
Baobab oil is often used in traditional medicine as antipyretic, antioxidant, anti-inflammatory, analgesic and antimicrobial. It also regenerates the epithelial tissue in a short time improving tone and elasticity. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Superficial Bladder Cancer, Lower Urinary Tract Symptoms
- What is being tested?
- Intravesical baobab oil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Complete transurethral resection of primary histologically proven high risk urothelial non-muscle invasive bladder tumors: high grade (G3,) stage pTa, pT1, and carcinoma in situ (pTis
- Intravesical BCG treatment
- Adequate bone marrow reserve (ie, white-blood-cell count ≥4000 x106 cells/L and platelet count
- ≥120 x 109/L
- Normal renal function (function (ie, serum creatinine ≤123•76 µmol/L)
- normal liver function ((ie, serum glutamic-oxaloacetic transaminase ≤42 U/L, serum glutamic-pyruvic transaminase ≤48 U/L, and total bilirubin ≤22•23 µmol/L)
- Karnofsky performance score of 50 to 100
Who cannot join
- Previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs
- Previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both
- Previous muscle-invasive (ie, stage T2 or higher) urothelia carcinoma of the bladder
- Known allergy to baobab oil
- Bladder capacity less than 200 mL
- Untreated urinary-tract infection
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- Severe systemic infection (ie, sepsis)
- Urethral strictures that would prevent endoscopic procedures and catheterisation
- Disease of upper urinary tract (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures at risk
- Previous radiotherapy to the pelvis;
- Other concurrent chemotherapy;
- Treatment with radiotherapy-response or biological-response modifiers;
- Other malignant diseases within 5 years of trial registration (except for basal-cell carcinoma);
- Pregnancy or nursing;
- Psychological, familial, sociological, or geographical factors that would preclude study participation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms: a Phase I-II Study
Baobab oil is often used in traditional medicine as antipyretic, antioxidant, anti-inflammatory, analgesic and antimicrobial. It also regenerates the epithelial tissue in a short time improving tone and elasticity. We want to evaluate the effects of intravesical Baobab oil in patients with BCG-induced lower urinary tract symptoms.
Read the detailed description
After complete transurethral resection of primary high risk non-muscle invasive bladder tumors (stage pTa, pT1, carcinoma in situ and high grade urothelial carcinoma), patients on induction course of intravesical BCG with lower urinary tract symptoms unresponsive to standard therapies are enrolled. The patients supply written informed consent to a document describing the investigational nature of the protocol.
Induction treatment consists of an initial 6 intravesical BCG treatments at weekly interval commencing approximately 3 weeks after transurethral resection procedures. The BCG instillation consisted of 81 mg wet weight (10•2±9•0 x 108 colony-forming units) BCG Connaught substrain. Lyophilised (ie, freeze-dried) BCG is suspended in 50 mL bacteriostatic-free solution of 0•9% sodium chloride. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 120 min, followed by emptying of the bladder and removal of the catheter.
During BCG treatment patients with persistent lower urinary tract symptoms unresponsive to standard therapies (anticholinergics, alpha-blockers, antibiotics, analgesics and anti-inflammatory drugs) are treated with an intravesical instillation of 50 ml sterile Baobab natural oil (Baotrophic, Physion Srl, Mirandola, Italy). After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 60 min, followed by emptying of the bladder and removal of the catheter.
Lower urinary tract symptoms are self-recorded by the patients before and after each baobab oil instillation and classified by the investigator according to a classification grid considering account duration and intensity. The classification of symptoms is class 0= none, class I = mild, class II = moderate, and class III = severe, according to severity. Local adverse events are cystitis, nocturia, pollakiuria, micturition urgency, micturition burning, stress urinary incontinence, dysuria, hematuria, pelvic pain, and perineal pain. The outcome measures are analyzed before and every day for one week after treatment. All patients are assessed for safety.
- Being tested
- Intravesical baobab oil
- Keywords
- High risk non-muscle invasive urothelial bladder cancer, Intravesical BCG, Local toxicity, Natural baobab oil
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical baobab oilDevice
Also called Baotrophic, Physion Srl, Mirandola, Italy
Intravesical baobab oil
| Study group | Role | What they receive |
|---|---|---|
| Intravesical baobab oil | Experimental | Intravesical instillation of 50 ml sterile Baobab natural oil. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 60 min, followed by emptying of the bladder and removal of the catheter. Receives: Device: Intravesical baobab oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative symptom score questionnaire
A quantitative symptom score questionnaire is completed by the patients before treatment to establish baseline symptoms and daily during the following 7 days after treatment. The questionnaire is designed to evaluate 10 lower urinary tract symptoms (cystitis, nocturia, pollakiuria, micturition urgency, micturition burning, stress urinary incontinence, dysuria, hematuria, pelvic pain, and perineal pain. Most symptoms are scored on a 0 to 3-point scale, corresponding to none/mild/moderate/severe.
Measured: 36 months
Secondary outcomes (1)
Baobab oil toxicity
All patients are assessed for safety or allergy to intravesical baobab oil
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Savino M. Di Stasi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari
- Responsible party
- Sponsor-investigator, Savino M. Di Stasi, University of Rome Tor Vergata
- Investigators
- Savino M Di Stasi, MD, PhD, Study chair, Tor Vergata University, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939756
- Sponsor's protocol ID
- UTV-101-2012
- Acronym
- Baobab
- Status last verified
- Sep 2013
- First submitted
- 2 Sep 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms: a Phase I-II Study
- ClinicalTrials.gov ID
- NCT01939756
- Acronym / sponsor ID
- Baobab / UTV-101-2012
- Keywords
- High risk non-muscle invasive urothelial bladder cancer, Intravesical BCG, Local toxicity, Natural baobab oil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Savino M. Di StasiUniversity, hospital or other
- Collaborators
- University of Bari
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Baobab oil is often used in traditional medicine as antipyretic, antioxidant, anti-inflammatory, analgesic and antimicrobial. It also regenerates the epithelial tissue in a short time improving tone and elasticity. We want to evaluate the effects of intravesical Baobab oil in patients with BCG-induced lower urinary tract symptoms.
Detailed description
After complete transurethral resection of primary high risk non-muscle invasive bladder tumors (stage pTa, pT1, carcinoma in situ and high grade urothelial carcinoma), patients on induction course of intravesical BCG with lower urinary tract symptoms unresponsive to standard therapies are enrolled. The patients supply written informed consent to a document describing the investigational nature of the protocol.
Induction treatment consists of an initial 6 intravesical BCG treatments at weekly interval commencing approximately 3 weeks after transurethral resection procedures. The BCG instillation consisted of 81 mg wet weight (10•2±9•0 x 108 colony-forming units) BCG Connaught substrain. Lyophilised (ie, freeze-dried) BCG is suspended in 50 mL bacteriostatic-free solution of 0•9% sodium chloride. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 120 min, followed by emptying of the bladder and removal of the catheter.
During BCG treatment patients with persistent lower urinary tract symptoms unresponsive to standard therapies (anticholinergics, alpha-blockers, antibiotics, analgesics and anti-inflammatory drugs) are treated with an intravesical instillation of 50 ml sterile Baobab natural oil (Baotrophic, Physion Srl, Mirandola, Italy). After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 60 min, followed by emptying of the bladder and removal of the catheter.
Lower urinary tract symptoms are self-recorded by the patients before and after each baobab oil instillation and classified by the investigator according to a classification grid considering account duration and intensity. The classification of symptoms is class 0= none, class I = mild, class II = moderate, and class III = severe, according to severity. Local adverse events are cystitis, nocturia, pollakiuria, micturition urgency, micturition burning, stress urinary incontinence, dysuria, hematuria, pelvic pain, and perineal pain. The outcome measures are analyzed before and every day for one week after treatment. All patients are assessed for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravesical baobab oil | Experimental | Device: Intravesical baobab oilIntravesical instillation of 50 ml sterile Baobab natural oil. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 60 min, followed by emptying of the bladder and removal of the catheter. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Complete transurethral resection of primary histologically proven high risk urothelial non-muscle invasive bladder tumors: high grade (G3,) stage pTa, pT1, and carcinoma in situ (pTis
- Intravesical BCG treatment
- Adequate bone marrow reserve (ie, white-blood-cell count ≥4000 x106 cells/L and platelet count
- ≥120 x 109/L
Key exclusion criteria (15 listed)
- Previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs
- Previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both
- Previous muscle-invasive (ie, stage T2 or higher) urothelia carcinoma of the bladder
- Known allergy to baobab oil
- Bladder capacity less than 200 mL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical baobab oilAlso: Baotrophic, Physion Srl, Mirandola, ItalyIntravesical baobab oil | Device | Intravesical baobab oil |
Primary outcome
Quantitative symptom score questionnaire
Time frame: 36 months
A quantitative symptom score questionnaire is completed by the patients before treatment to establish baseline symptoms and daily during the following 7 days after treatment. The questionnaire is designed to evaluate 10 lower urinary tract symptoms (cystitis, nocturia, pollakiuria, micturition urgency, micturition burning, stress urinary incontinence, dysuria, hematuria, pelvic pain, and perineal pain. Most symptoms are scored on a 0 to 3-point scale, corresponding to none/mild/moderate/severe.
1 secondary outcome
Baobab oil toxicity
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savino M Di Stasi, MD, PhD study chair
Tor Vergata University, Rome, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravesical baobab oil in people with Superficial Bladder Cancer and Lower Urinary Tract Symptoms, run by Savino M. Di Stasi at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative symptom score questionnaire (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.