Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Prostatic Hyperplasia

Hyperplasia

Lower Urinary Tract Symptoms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urological Manifestations

All Drugs and Chemicals

Vasodilator Agents

Botulinum Toxins

Botulinum Toxins, Type A

abobotulinumtoxinA

incobotulinumtoxinA

Acetylcholine

Cholinergic Agents

Neurotransmitter Agents

A total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml).

BOTOX

Gusatavo E. Ayala, MD

This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections into the right peripheral and transition zones and sham saline injections into the left peripheral and transition zones.

For the purposes of this study, patients are treated with the presentation of botulinum toxin type A which is marketed in the U.S. as BOTOX® by Allergan. BOTOX® is a purified neurotoxin complex supplied as a sterile, vacuum dried purified botulinum toxin type A, produced from fermentation of Clostridium botulinum type A.

A primary aim of this study is to determine the molecular effects of BoNT-A injection on human BPH tissues. While the majority of BoNT-A injections in humans target BPH in the transition zone, innervation is most abundant in the peripheral zone of the prostate where the majority of prostate cancers develop. In fact, recent studies have demonstrated the importance of neurogenesis and axogenesis in the spread of human prostate cancer. In addition, in vitro studies have shown that BoNT-A has antiproliferative effects on human prostate cancer cell lines.

Thus, a second aim of this proposal is to determine profile changes in high-grade prostatic intraepithelial neoplasia (HGPIN) and prostate cancer following BoNT-A injection into the peripheral zone. The investigators will also determine the effects of BoNT-A on the genetic profile of normal tissue. The investigators study population will be men with clinically localized prostate cancer. Men will be injected on one side in both their transition and peripheral zones with 100U BoNT-A (i.e. Botox®, Allergan, Inc.), respectively, one month prior to their scheduled radical prostatectomy. Sham saline injection of the other side of the prostate (transition and peripheral zones) will be used as an internal control. The investigators will inject the other lobe of the prostate with saline to account for any denervating effects of "wet needling." Patients will undergo radical prostatectomy without any changes to standard of care. The strategy has been used in the investigators Institution previously to determine the efficacy of gene therapy 22 and targeted drugs. However, and unlike the investigators previous neoadjuvant trials, the investigators will not power this study to look at the effects of Botox on biochemical recurrence free survival. This study only has biologic endpoints and no survival endpoints."

A third aim of the study will be to examine changes in vas deferens function following prostate treatment with BoNT-A. The investigators plan to harvest a 2.5 cm segment from the distal vas deferens on either side (i.e. Saline treated and BoNT-A treated) before entry into the prostate will be isolated and placed in oxygenated krebs solution for transport to the research laboratory.

Patients will have 3 visits to the clinic and two telephone calls during their participation in this study. The last visit is about 4 weeks after the injection.

BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)

H-25362: Effect of Botulinum Neurotoxin Type A Prostate Injections on Neurogenesis and Gene Profile Expression in Men With Localized Prostate Cancer and Lower Urinary Tract Symptoms/BPH (Protocol # 05-09-30-03)

The prostate tissue taken from each lobe will be compared to determine if the injection of BOTOX has effected the genetic profile.

Any changes to the vas deferens tissue after BOTOX injection, will be noted.

The University of Texas Health Science Center, Houston

Professor and Distinguished Chair in Pathology and Laboratory Medicine

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Rare Diseases

Lung Neoplasms

Pain, Postoperative

Syndrome

Chronic Pain

Pain

Neuralgia

Neurologic Manifestations

Postoperative Complications

Peripheral Nervous System Diseases

Neuromuscular Diseases

Chronic Graft Versus Host Disease

Pharmaceutical Solutions

Onabotulinum toxin A is reconstructed with 4 ml of normal saline in a vial containing 100 U (Allergen Units).

At a single treatment session, test subjects receive a series of subcutaneous injections with 2,5 U Onabotulinum toxin A equivalent to 0,1 ml of solution after reconstruction. One injection is given per 1 square centimeter in the painful area in relation to the scar on the chest wall. The maximum number of subcutaneous injections is 40, equivalent to a maximum dose of 100 U of Onabotulinum toxin in a total volume of 4 ml solution. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes.

At a single treatment session, test subjects receive a series of subcutaneous injections with one injection per 1 square centimeter in the painful area in relation to the scar on the chest wall with an inert solution, i.e. 0.1 ml injections of normal saline up to a total volume of 4 ml, depending on the area of the painful area. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes.

Onabotulinum Toxin A

Normal saline

Allan V Danielsen, MD

Jan J Andreasen, MD PhD

Chronic postsurgical pain following lung cancer surgery is common with and 20-60 % develop chronic pain which persists more than six months after surgery. Causes and health impact of this pain have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.

Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized controlled trials (RCT) have been executed to date.

Study objectives:

Determine recruitment potential among cured lung cancer patients with chronic postsurgical pain for an RCT and if the method of BTX-A administration is feasible and acceptable. Further more, this study will contribute to the stage testing of the hypothesis that chronic pain following thoracic surgery can be treated with BTX-A.

Methods:

Recruitment of test subjects:

Participiants are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail.

Randomization and blinding:

Participants are randomized to receive a single series of subcutaneous injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo) at the former operation site. Neither participant nor investigator will know which treatment is given until the end of the trial.

Data collection:

Data is collected by questionnaires delivered and answered by mail or digitally.

Data on the possible effects and possible adverse reactions are collected at multiple times until three months after treatment.

Chronic postsurgical pain (CPP) following lung cancer surgery is common with an observed prevalence of 20-60 %. Causes and health impact have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.

Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized clinical controlled trials (RCT) has been executed to date.

Study objectives:

Primary:

Determine recruitment potential among cured lung cancer patients with CPP for an RCT and if the method of BTX-A administration is feasible and acceptable to the test subjects.

Secondary:

Early stage testing of the hypothesis that CPP following thoracic surgery can be treated with this novel method.

Methods:

Recruitment of test subjects:

Test subjects are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail.

Randomization and blinding:

Test subjects are randomized to receive a series of injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo). Neither test subject nor investigator will know which treatment is given until the end of the trial.

Experimental treatment:

The investigator examines the skin area of the test subject at the operation site and performs a sensory examination with pin prick and sensory brush. The area is located and marked and divided into quadrants of one square centimeter. An area of maximum 40 square centimeters is marked.

At a single treatment session, test subjects receives either active agent or placebo through a series of subcutaneous injections. One injection is given in each marked quadrant of the treatment area. The maximal number of injections is 40.

Follow-up:

After the treatment, test subjects report pain symptoms and intensity, use of pain medication and occurrence of adverse events weekly.

After 30 and 90 days after treatment more comprehensive and additional data is collected concerning neuropathic symptoms, activities of daily life, general health and level of function.

Data collection Data is collected by questionnaires delivered to test subjects by mail or digitally.

Endpoints:

Primary:

1. Recruitment of 30 test subjects.
2. Half of the first half of included test subject must complete the treatment.
3. Half of test subjects in total mus complete the treatment.

Secondary:

1. Pain at rest, coughing and when active Numerical rating score (NRS) for presence of pain before and after treatment and course of pain symptoms.
2. General Health Short form 36 Health Survey on physical, social and mental level of function on a score from 0 to 100.
3. Neuropathic Pain Symptoms Inventory (NPSI) NRS
4. Activities of daily life Impact and intensity of pain categorically in 16 situations of daily life.
5. Patient's Global Impression of Change (PGIC) Rating of global change perceived by the test subject from "More Worse" to "Much better" and a scale from 0 to 10.

Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery

Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery: a Randomized Controlled Pilot Trial

Half of the first half of included test subject must complete the treatment.

Recruitment of 30 test subjects within twelve months.

Proportion of test subjects terminating the treatment procedure after randomization by request due to unacceptable pain or discomfort during the procedure.

Numeric Rating Scale, range 0 (no pain) to 10 (worst pain imaginable) in whole numbers

Impact and intensity of pain categorically in 16 situations of daily life. Categorically reported as "Avoid", "Major restriction", "Some restriction", "Minor restriction", "No restriction" or "Do not perform"

Rating of global change perceived by the test subject from "More Worse" to "Much better" and a scale from 0 to 10.

Short form 36 Health Survey on physical, social and mental level of function on a score from 0 to 100.

Evaluation of pain/discomfort at administration of BTX-A using subcutaneous injection in the skin of the chest wall. Numeric Rating Scale, range 0 (no pain) to 10 (worst pain imaginable) in whole numbers

Allan Vestergaard Danielsen, MD

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

The trial was a comparison between each breast in a single patient undergoing bilateral mastectomy with reconstruction

In each patient enrolled in the study, botulinum toxin was injected into one pectoralis muscle while saline placebo was injected on the opposite side in a randomized blinded fashion

Bilateral mastectomy with reconstruction

Joyce K Aycock, MD

Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.

A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders

Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)	NCT01520441	Prostate Cancer Benign Prostati... Enlarged Prosta...	BOTOX	50 Years -	The University of Texas Health Science Center, Houston
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)	NCT01520441	Prostate Cancer Benign Prostati... Enlarged Prosta...	BOTOX	50 Years -	The University of Texas Health Science Center, Houston
Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery	NCT04585620	Chronic Pain Post-thoracotom... Pain, Neuropath... Pain, Postopera...	Onabotulinum To... Normal saline	18 Years -	Aalborg University Hospital
A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders	NCT01765309	Breast Cancer	Bilateral maste...	18 Years -	University of Colorado, Denver

Spots Global Cancer Trial Database for botulinum toxin