Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Vasodilator Agents

Urological Agents

Dermatologic Agents

Anticoagulants

Other Dietary Supplements

Cytarabine

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Azacitidine

Decitabine

Melphalan

Nivolumab

Sildenafil Citrate

Tretinoin

Citric Acid

Sodium Citrate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

Antiviral Agents

Enzyme Inhibitors

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Keratolytic Agents

Citrate

Nivolumab 1 mg/kg days 1,15 iv q28days Fludarabine 25 mg/m2 days 1-3 iv q28days Cyclophosphamide 300 mg/m2 days 1-3 iv q28days

Nivolumab 1 mg/kg days 1,15 iv q28days Cytarabine 10 mg/m2 bid days 1-10 sc q28days All-trans retinoic acid (ATRA) 45 mg/m2 po qd

Nivolumab 1 mg/kg days 1,15 iv q28days Cytarabine 10 mg/m2 bid days 1-10 sc q28days Sildenafil 20 mg tid

Nivolumab 1 mg/kg days 1,15 iv q28days Melphalan 2 mg qd days 1-10 q28days

Nivolumab 1 mg/kg days 1,15 iv q28days 5-azacitidine 75 mg/m2 days 1-7 q28days

1 mg/kg by vein on Days 1 and 15 of a 28 day cycle

75 mg/m2 subcutaneously on Days 1-7 of a 28 day cycle

25 mg/m2 by vein on Days 1, 2 and 3 of a 28 day cycle. Dose reduction to 15 mg/m2 is permitted in cases of grade 4 hematological toxicity after first cycle.

300 mg/m2 by vein on Days 1, 2 and 3 of a 28 day cycle.

10 mg/m2 subcutaneously two times a day on Days 1-10 of a 28 day cycle

45 mg/m2 per os daily during the whole course of treatment

all trans retinoic acid

20 mg per os three times a day during the whole course of treatment

Sildenafil

2 mg per os daily during the whole course of treatment

There is evidence of involvement of checkpoint pathways, including PD-1, in the pathogenesis and resistance of myelodysplastic syndrome (MDS). However monotherapy with checkpoint inhibitors was ineffective in a number of studies, indicating the presence of several mechanisms of resistance. This pilot study evaluates the safety and preliminary efficacy of nivolumab combination with currently existing treatments in MDS patients who failed at least one line of therapy. The study evaluates if there is a combination which induces objective responses.

Nivolumab With Chemotherapy in Refractory MDS

Pilot Open-label Trial of Nivolumab Combined With Chemotherapy in Refractory Myelodysplastic Syndromes.

Overall response rate (ORR) defined as complete response plus partial response (CR + PR) and hematological improvement (HI). MDS International Working Group criteria will be used to assess response.

Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).

Incidence of severe bacterial, fungal and viral infections incidence based on laboratory confirmation and attending physician assessment

St. Petersburg State Pavlov Medical University

Vice-director for science, R.M. Gorbacheva memorial institute

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Sarcoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Soft Tissue Sarcoma

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Patients receive sildenafil citrate PO QD\* beginning at least 2 days prior to scheduled first dose of doxorubicin hydrochloride and continuing until 2 weeks after last scheduled dose of doxorubicin hydrochloride. Patients also receive doxorubicin hydrochloride IV as clinically indicated and as prescribed by treating provider.

NOTE: \*Patients receive sildenafil citrate PO TID on days that doxorubicin hydrochloride is also administered.

Patients receive doxorubicin hydrochloride IV as clinically indicated and as prescribed by treating provider.

Andrew S. Poklepovic, MD

Sildenafil increases the therapeutic effect of doxorubicin used as treatment for cancers of solid tumors through both an increase in anti-tumor effects and protection from cardiac toxicity.

Definitive study of sildenafil enhancement of anthracycline anticancer effects and cardioprotection would require a randomized, placebo-controlled trial involving large numbers of patients and many years of follow-up. It is appropriate to demonstrate that concurrent administration of sildenafil and doxorubicin is safe and tolerable. Second, in definitive studies it might be helpful to incorporate early markers of cardiac injury in order to gain early insight into cardioprotective effects, but there are no such established markers. As a correlative study, multiple intermediate markers will be tested. In order to investigate these candidate markers it is appropriate to study patients receiving doxorubicin alone, as early markers of injury may not be apparent in patients treated with the combination. In order to accomplish these two goals the trial is a randomized trial involving a sildenafil/doxorubicin group and a doxorubicin group.

Doxorubicin With or Without Sildenafil, With Analysis of Cardiac Markers

Randomized Open-label Phase 1b Study of Doxorubicin-based Chemotherapy Regimens, With and Without Sildenafil, With Exploratory Analysis of Intermediate Cardiac Markers

Sildenafil will be administered at least 7 days prior to scheduled first dose of doxorubicin and continue daily dosing through 2 weeks after last doxorubicin dose. Multiple biomarkers as candidate early markers of anthracycline-induced cardiotoxicity will be tested.

A repeated measures analysis of variance (ANOVA) will be used to compare the LVEF between Arm 1 and Arm 2 over all visits. A pooled t-test will also be performed to determine the change in LVEF between first and last visits.

The fluctuation in the levels of biomarkers including novel ultra sensitive troponins and BNP, as well as tissue doppler imaging studies with echocardiography will analyzed.

Virginia Commonwealth University

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Sildenafil plus carboplatin and weekly paclitaxel

sildenafil

placebo

paclitaxel; 70mg/m2 div on day 1, 8 and 15, every 28 days

paclitaxel (taxol)

carboplatin; AUC=6 on day 1, every 28 days

carboplatin (palaplatin)

Kingo Chida, MD,PhD

A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with carboplatin and weekly taxol in patients with previously untreated advanced non-small cell lung cancer. The study hypothesis is that sildenafil may improve the distribution and efficacy of cytotoxic anticancer agents.

Sildenafil is one of selective phosphodiesterase type 5 inhibitors. It is used to block the degradative action of phosphodiesterase type 5 on cyclic GMP in the smooth muscle cells lining the blood vessels, which leads to smooth muscle relaxation in blood vessels and increases blood flow. Because phosphodiesterase type 5 is also present in the arterial wall smooth muscle within the lungs, phosphodiesterase type 5 inhibitors is also used for the treatment of pulmonary hypertension.

Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Randomized Phase II Study of Combination Chemotherapy With Sildenafil Plus Carboplatin and Weekly Paclitaxel in Patients With Previously Untreated Advanced Non-small Cell Lung Cancer

Hamamatsu University

Department of Respiratory Medicine

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Christian P Pavlovich, MD

The ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. Patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to "as needed" sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one NVB was spared. This study has been designed to determine if sildenafil taken nightly works better than sildenafil on as "as needed" basis for the return of erectile function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.

Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy

Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy

Johns Hopkins University

Christian Pavlovich, M.D.

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Fatigue

Cholangiocarcinoma

Pancreatic Neoplasms

Wasting Syndrome

Cachexia

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Pancreatic Cancer

Bile Duct Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

Melinda Sheffield-Moore, PhD

Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.

This is a double-blinded, placebo-controlled trial in men and women, 40-75 years old, diagnosed with pancreatic or cholangiocarcinoma cancer. Patients will receive placebo or sildenafil daily for 4 weeks during their initial chemotherapy cycle.

Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer

Phase I Assessment of NO Mediated Signaling in Cancer Cachexia

Lean body mass will be measured by DEXA scan

Skeletal muscle fatigue will be measured by leg dynamometer.

The University of Texas Medical Branch, Galveston

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Sildénafil during 10 months (50mg daily), start 30 days after surgery

Patients receive placebo during 10 month (1 platelet per day)

1 platelet during 10 months (daily), start 30 days after surgery

Placebo

Valérie Bridoux

Julie Rondeaux, PhD

This study aims to evaluate the efficacy of erectile rehabilitation with Sildenafil, in men treated with neoadjuvant proctectomy and radiotherapy for rectal cancer, in preventing long-term erectile dysfunction at 12 months post-operatively.

Colorectal cancer is the third most common cancer in men in France, after lung and prostate cancer. Proctectomy (possibly preceded by radiotherapy) is the most effective treatment for this cancer, but erectile dysfunction (ED) is a frequent complication, even when the nerves are preserved during dissection, and has a major impact on the quality of life of operated men.

The cause of erectile dysfunction after rectal cancer surgery is usually neurological, due to intraoperative trauma to the autonomic nerves, while erectile dysfunction after radiotherapy is mainly vascular in origin, with damage to erectile tissue.

Several risk factors for sexual dysfunction after rectal cancer surgery have been reported (age, neoadjuvant radiotherapy, type of resection, operative difficulties and complications, body image affected by protective stoma). On the other hand, surgical expertise may be a protective factor.

In the physiological condition, the nitric oxide released by the pelvic nerves causes an increase in cyclic guanosine monophosphate, which in turn causes smooth muscle cells relaxation and an influx of blood into the cavernous body, triggering and maintaining the erection.

Similar to prostatectomy, nerve damage can occur during proctectomy through stretching, heat, ischemia or inflammation; this nerve damage results in reduced nitric oxide production.

Even in the absence of nerve damage, it has been demonstrated (in an animal model) that post-operative neurapraxia is responsible for the at least temporary disappearance of spontaneous and nocturnal erections, leading to cavernous hypoxia. This is followed by tissue changes (reduction in smooth and elastic muscle fibers in the corpora cavernosa, increase in collagen and endothelial dysfunction), which modify the hemodynamics of the carvernum body and ultimately lead to fibrosis of the erectile tissue.

These changes can become permanent despite subsequent nerve recovery, and are exacerbated by neoadjuvant radiotherapy. It is therefore important not to wait passively for erectile function to be restored, as lack of oxygenation to the corpora cavernosa can lead to permanent fibrosis and dysfunction.

This physiopathology is at the origin of the concept of erectile rehabilitation after prostatectomy, with the aim of maintain erections post-operatively and thus limiting fibrosis.

The benefits of erectile re-education after prostatectomy were first reported in 1997, with the early use of intracavernous injections of alprostadil. Following this study, various rehabilitation strategies have been recommended. Early treatment, i.e. within the first month, is recommended to promote cavernous oxygenation and prevent fibrosis.

The aims of rehabilitation are as follows :

* limit fibrosis;
* limit penis retraction and loss of height;
* oxygenate the cavernum body;
* preserve endothelial structure;
* preserve smooth muscle cell structure.

Various types of rehabilitation have been proposed: oral PDE-5 inhibitors, intra-cavernosal injections, urethral suppositories or vaccum.

PDE-5 inhibitors prevent the degradation of cyclic guanosine monophosphate, thus compensating for the reduction in nitric oxide and enabling a better erection.

Erectile rehabilitation using PDE-5 inhibitors could protect cavernous smooth muscle from irreversible pathophysiological changes. The basic concept is to administer a PDE-5 inhibitor at bedtime to facilitate nocturnal erections, which are thought to have a natural protective effect on the function of the cavernous bodies.

Padma-Nathan et al. reported the prospective administration of sildenafil 50 and 100 mg vs. placebo, daily and at bedtime, in patients undergoing nerve-sparing radical prostatectomy. After 36 weeks, erectile function was significantly better in the sildenafil group, with 27% responders, vs. 4% in the placebo group.

The mechanisms involved in erectile dysfunction after proctectomy for rectal cancer are similar to those of radical prostatectomy for prostate cancer.

The efficacy of PDE-5 inhibitors in the treatment of erectile dysfunction after proctectomy has already been demonstrated. However, its use as a preventive measure has rarely been reported.

Three studies have evaluated PDE-5 inhibitors in patients with erectile dysfunction after rectal resection, two of which used sildenafil (Viagra, Pfizer, New York, NY)

To our knowledge, only one study has evaluated the role of PDE-5 inhibitors (PDE-5i) in a preventive strategy.

Originality and innovation Despite the fact that sexual dysfunction is recognized as a frequent complication of rectal cancer treatment, there are currently no recommendations for its prevention and management.

In contrast to prostate cancer patients, information and treatment concerning erectile dysfunction (ED) are not systematically offered to men with colorectal cancer. The ability of sildenafil to facilitate the return of erections after radical prostatectomy has been demonstrated in several studies, and this treatment could benefit patients treated for rectal cancer.

To date, no randomized study has examined the usefulness of this early rehabilitation in patients managed for rectal cancer. This study proposes, for the first time, to evaluate the use of sildenafil after neo-adjuvant radiotherapy and surgery for rectal cancer.

Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer

Intérêt de la rééducation érectile précoce Par Sildénafil après radiothérapie et Proctectomie Pour Cancer du Rectum : Essai contrôlé randomisé

A patient is defined as a responder by a score of at least 22 for the erectile function domain of the International Index of Erectile Function (IIEF), comprising the six IIEF questions relating to erection (Q1-Q5 and Q15).

Mesure of IIEF erectile function domain score, comprising the six IIEF erectile function questions (Q1-Q5 andQ15) at D0, M1, M3, M6, M9 and M12

International Index of Erectile Function (IIEF) global score measured at D0, M1, M3, M6, M9 and M12

Mesure of quality of life score (EORTC QLQ - C30 and QLQ - CR29) at D0, M1, M3, M6, M9 and M12

LARS score measured at D0, M1, M3, M6, M9 and M12

Fecal Continence Score (Wexner score) measured at D0, M1, M3, M6, M9 and M12

Number of patients with spontaneous erections on treatment at M3, M6, M9 and without treatment at M1, and M12

The number of patients with or without regular psychological follow-up. A patient is defined as having regular follow-up if he/she visits a psychologist and/or psychiatrist once or twice a month.

Number of unused tablets during the study. The patient will be considered as non-compliant if pill-taking over the entire 10-month treatment period is \<80%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nivolumab With Chemotherapy in Refractory MDS	NCT03259516	Myelodysplastic...	Nivolumab Azacitidine Fludarabine Cyclophosphamid... Cytarabine all trans retin... Sildenafil Melphalan	18 Years - 80 Years	St. Petersburg State Pavlov Medical University
Nivolumab With Chemotherapy in Refractory MDS	NCT03259516	Myelodysplastic...	Nivolumab Azacitidine Fludarabine Cyclophosphamid... Cytarabine all trans retin... Sildenafil Melphalan	18 Years - 80 Years	St. Petersburg State Pavlov Medical University
Doxorubicin With or Without Sildenafil, With Analysis of Cardiac Markers	NCT01375699	Breast Cancer Gastrointestina... Genitourinary C... Sarcoma Gynecologic Can...	Doxorubicin Sildenafil	18 Years -	Virginia Commonwealth University
Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer	NCT00752115	Non-small Cell ...	sildenafil placebo paclitaxel (tax... carboplatin (pa...	40 Years - 75 Years	Hamamatsu University
Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy	NCT00511498	Prostate Cancer	Sildenafil	18 Years - 64 Years	Johns Hopkins University
Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer	NCT02106871	Pancreatic Canc... Cholangiocarcin...	Sildenafil	40 Years - 75 Years	The University of Texas Medical Branch, Galveston
Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer	NCT00752115	Non-small Cell ...	sildenafil placebo paclitaxel (tax... carboplatin (pa...	40 Years - 75 Years	Hamamatsu University
Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer	NCT06123156	Rectal Cancer	Sildenafil Placebo	18 Years - 70 Years	University Hospital, Rouen
Sildenafil for the Treatment of Lymphatic Malformations	NCT02335242	Lymphatic Malfo... Lymphatic Disea...	Sildenafil 20 m... Placebo tablets...	6 Months - 10 Years	Stanford University

Spots Global Cancer Trial Database for sildenafil

Every month we try and update this database with for sildenafil 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 sildenafil

Every month we try and update this database with for sildenafil 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 sildenafil 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.