Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Hot Flashes

Breast Diseases

Skin Diseases

Quality of Life

All Drugs and Chemicals

Antihypertensive Agents

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Aromatase Inhibitors

Clonidine

Solifenacin Succinate

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Cholinergic Agents

oral solifenacin 5.0 mg daily for 3 weeks

solifenacin

Allen C Sherman, PhD

Hot flashes present a considerable problem for many breast cancer patients; these symptoms may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in reducing hot flashes, compared with clonidine (a medication often used for treating hot flashes).

There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients

A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy

to evaluate changes in hot flash composite and frequency scores for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine

to evaluate changes in number of adverse events for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine

to evaluate changes in daily functioning (Hot Flash-Related Daily Interference Score) for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine

to evaluate changes in health-related quality of life. (Additional analyses will be observational, exploring associations between quality of life and meaning-making.)

University of Arkansas

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Cystitis

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Infective Agents

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Ofloxacin

BCG Vaccine

Lornoxicam

Anti-Bacterial Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

(Sofenacin ''solifenacin 10 m'') \[Marcyrl Pharmaceutical Industries - Egypt\]

(Tavanic ''levofloxacin 500 mg'') \[Sanofi-Aventis - Egypt\]

(Xefo ''lornoxicam 8 mg'') \[Multi-Apex - Egypt, under license of: NYCOMED, Austria\]

solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation

sofenacin

levofloxacin 500 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.

Tavanic

lornoxicam 8 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.

Xefo

Hassan Abol-Enein, MD, Phd

Ahmed Mosbah, MD

Ahmed Elhussein, MBBCH

Ahmed Elkarta, MBBCH

Mohamed Soltan

Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)

For urothelial carcinoma (UC), which accounts for over 90% of bladder cancers, more than 70% of bladder cancer patients present with non-muscle-invasive disease. Approximately 40-80% of these tumors will recur within the first year, of which 10-25% will progress to muscle-invasive disease.

Intravesical treatments with cytotoxic chemotherapy and immunotherapy have become the mainstay following transurethral resection (TUR). Increasing knowledge of BCG use allows for effective management of these once debilitating side effects. The majority of patients will still experience cystitis-like symptoms to some degree, including urinary frequency (71%), cystitis (67%), fever (25%), and hematuria (23%).

Oxybutynin increases in fever, flu-like symptoms, dry mouth and constipation. However, in this study oxybutynin started the night before treatment causing an element of incomplete bladder emptying and allowing an increased BCG dwell time. We think that these effect can be reversed by use anticholinergic 6 hours post BCG instillation Anti-inflammatory drugs significantly reduced BCG-induced granulocyte activation and did not impair BCG-induced lymphocyte cytotoxicity against bladder tumor cells in mice. The committee of International Bladder Cancer Group (IBCG) recommend use of anti-inflammatory agents (NSAIDs) for treatment of non-bacterial or chemical cystitis and other systemic BCG side effect.

Fluoroquinolone with tuberculostatic properties, has been shown to significantly prolong survival in mice with BCG systemic infection and did not affect the antitumor efficacy of BCG. ofloxacin significantly decreased by 18.5% the incidence of class II or higher moderate and severe adverse events of BCG.

Because of sparse published studies on BCG side effect management, the 2016 European Association of Urology (EAU) guidelines management options for side effects associated with intravesical BCG modify the IBCG committee clinical practice without any degree of recommendation. So, in this study the investigators will try to fill the gap in the literature.

Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?

Solifenacin vs Levofloxacin vs Lornoxicam for Management of Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Side Effects A Single Blinded Randomised Controlled Study

meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

__ Outcome Measure by Four-class classification grid of BCG adverse events

__ Outcome Measure by overactive bladder symptoms scores and American Urological Association Symptom Index

__ Outcome Measure by PSA measure 1 and 3 months post instillation

__ Outcome Measure by Number of patients surviving for one year without tumor recurrence will be counted and compared

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients	NCT01530373	Hot Flashes Breast Cancer	solifenacin Clonidine	18 Years -	University of Arkansas
Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?	NCT03038321	Non-Muscle-inva... Bacillus Calmet... Intra-vesical I...	sofenacin Tavanic Xefo	18 Years - 80 Years	Mansoura University

Spots Global Cancer Trial Database for solifenacin

Every month we try and update this database with for solifenacin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for solifenacin

Every month we try and update this database with for solifenacin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for solifenacin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.