Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Symptoms and General Pathology

Urinary Bladder Neoplasms

Lower Urinary Tract Symptoms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

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Urological Manifestations

Pharmaceutical Solutions

All Drugs and Chemicals

BCG Vaccine

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.

Intravesical baobab oil

Savino M Di Stasi, MD, PhD

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.

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.

Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms

Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms: a Phase I-II Study

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.

All patients are assessed for safety or allergy to intravesical baobab oil

University of Bari

Savino M. Di Stasi

Associate Professor of Urology, MD, PhD

Skin and Connective Tissue Diseases

Rare Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Acute Graft Versus Host Disease

Intervention:

Intraoperative Radiotherapy

\* Operation day

* Breast conservative surgery + Intraoperative radiotherapy 20 Gy

Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity. Purse string suture pulles up tissues and wraps up the applicator. IORT with 20Gy is followed. After IORT, applicator was out of the operative field, and usual wound closure will be done.

\* Postoperative period

* ± Chemotherapy
* WBRT (46 Gy) for 4\~5 weeks
* ± Endocrine therapy or target therapy

Operation day

1. Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity.
2. Purse string suture pulles up tissues and wraps up the applicator.
3. Intraoperative radiotherapy using Intrabeam® (20Gy) is followed.
4. After IORT, applicator was out of the operative field, and usual wound closure will be done.

   * Postoperative period

     * Chemotherapy WBRT (46 Gy) for 4\~5 weeks
     * Endocrine therapy or target therapy

Intraoperative radiotherapy using Intrabeam®

Joon Jeong, M.D. Ph.D.

The purpose of this study is to evaluate acute local toxicity of IORT at the dose of 20 Gy for the replacement of boost-external beam radiotherapy in Korean women who are candidates for breast-conserving treatment.

Local toxicity checklist

* Hematoma needing surgical evacuation
* Seroma needing more than three aspirations
* Skin breakdown or delayed wound healing
* Any complication needing surgical intervention
* Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other.
* Any complication of RTOG toxicity grade more than 2

Evaluate the safety of intraoperative radiotherapy using Intrabeam in Korean patients with early breast cancer.

Intraoperative Radiotherapy for Korean Patients With Breast Cancer

A Phase II Trial Investigating Acute Local Toxicities of Intraoperative Radiotherapy as a Boost Dose in Korean Breast Cancer Patients Undergoing Breast Conserving Surgery

Acute local toxicities of ipsilateral breast occurred within 6 months after IORT

Local toxicity checklist

* Hematoma needing surgical evacuation
* Seroma needing more than three aspirations
* Skin breakdown or delayed wound healing
* Any complication needing surgical intervention
* Radiation Therapy Oncology Group (RTOG version 2.0) toxicity grade 3 or 4 for dermatitis, telangiectasia, pain in irradiated field, or other.
* Any complication of RTOG toxicity grade more than 2

Expected number of patients with acute local toxicites associated with IORT-booster treatement is 32.

Considering a drop-out rate of 10%, the trial would need to enroll 215 patients in total.

Monitoring of local toxicity evaluated at 2 years and 5 years

Questionnaire on cosmetic outcome of operation site Qualified assessment based on BCCT ver 2.0

-Dosimetry in tumor cavity and correlation with acute and late complication rates

* Identification of anatomical indication
* MRI volumetry (Breast-to-tumor ratio)
* Skin depth measured at preoperative US

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms	NCT01939756	Superficial Bla... Lower Urinary T...	Intravesical ba...	18 Years - 90 Years	University of Rome Tor Vergata
Intraoperative Radiotherapy for Korean Patients With Breast Cancer	NCT02213991	Breast Cancer	Intraoperative ...	18 Years -	Gangnam Severance Hospital

Spots Global Cancer Trial Database for local toxicity