Neoplasms

All Conditions

Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Flavonoid

Herbal and Botanical

Docetaxel

Fluorouracil

Silymarin

Cisplatin

Antioxidants

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Protective Agents

Milk Thistle

Placebo 420 mg daily in three divided doses for 65 days as control along with \[cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 +docetaxel 60-80 mg/m2\]

silymarin 420 mg daily in three divided doses for 65 days along with standard chemotherapy \[cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 +docetaxel 60-80 mg/m2 control

Silymarin 420 mg in 3 divided dose plus standard chemotherapy

placebo tablets: 420 mg in 3 divided dose

Placebo

All patients will receive standard chemotherapy: cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 + docetaxel 60-80 mg/m2

chemotherapy

Simin Dashti-Khavidaki, Dr

Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid tumours. acute renal failure, despite conservative fluid and electrolyte management, frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective, anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor, vascular endothelial growth factor and insulin-like growth factor-I have shown in the previous in-vitro studies.The aim of present study,a randomized double-blind placebo- controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus chemotherapy \[cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21 days\] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and urine electrolyte will be measured daily during chemotherapy.

changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity assessed up to 64 days.

This study will look for possible protective effects silymarin on kidney injury in patients receiving cisplatin.

Evaluation of Effects of Silymarin on Cisplatin Induced Nephrotoxicity in Upper Gastrointestinal Adenocarcinoma

Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity

All subject receive silymarin at dose of 420mg or placebo in three dose for 65 consecutive day, urine NGAL concentration will be measured.

To assess interaction between silymarin and cancer chemotherapy serum vascular endothelial growth factor will be measured.

To assess interaction between silymarin and cancer chemotherapy Tissue activity of caspase 3will be measured.

Tehran University of Medical Sciences

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Acute Kidney Injury

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Acute Graft Versus Host Disease

Hypoglycemic Agents

Dipeptidyl-Peptidase IV Inhibitors

Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment

Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment

Gemigliptin 100mg in 2 divided doses plus cisplatin

Gemigliptin

All patients will receive intravenous cisplatin

Ki Young Na

Hyunjin Cho

Ki Young Na, MD PhD

Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by acute kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4) inhibitors are well known to improve glucose intolerance by augmentation of endogenous glucagon like peptide (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4 inhibitor also has the potential anti-apoptotic and renoprotective effect in a mouse model of cisplatin-induced AKI. This is a single-center, randomized, double-blind, parallel-group, placebo-controlled, prospective study to investigate the renoprotective effect of DPP4 inhibitor on cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with cisplatin, will be recruited and randomly assigned to either Gemigliptin or placebo groups. Subjects will take study drugs for 8 days starting from one day before cisplatin treatment. Serum creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7 days after cisplatin treatment.

This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin induced acute kidney injury.

Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury

* Increase in sCr by ≥ 0.3 mg/dl
* Increase in sCr to ≥ 1.5 times baseline
* Decrease in eGFR to ≥ 25%

All subjects receive Gemigliptin or placebo at a total dose of 100mg (50mg twice a day) for 8 consecutive days, serum creatinine will be measured.

Change of serum creatinine from baseline to 7 days after cisplatin treatment.

Change of glomerular filtration rate calculated by the Chronic Kidney Disease Epidemiology Collaboration equations (CKD EPI) from baseline to 7 days after cisplatin treatment.

LG Life Sciences

Seoul National University Bundang Hospital

Professor

Ear, Nose, and Throat Diseases

Nervous System Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Head and Neck Neoplasms

Hearing Loss

Deafness

Ototoxicity

Hearing Disorders

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Neurologic Manifestations

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Anti-Infective Agents

Respiratory System Agents

Acetylcysteine

N-monoacetylcystine

Antiviral Agents

Expectorants

Antidotes

Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.

N Acetylcysteine

Placebo Oral Tablet

Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer. A Randomized, Placebo Controlled Clinical Trial

Hospital San Juan de Dios, Santiago

Otolaryngologist, Clinical Epidemiologist.

(n=25): receive cisplatin with hydration 1000mg magnesium (8 Meq) intravenous infusion ( IVI ).

(n=25): receive cisplatin with hydration 2000mg magnesium (16 Meq) ( IVI ).

(n=25): receive cisplatin with hydration 3000 mg magnesium (32 Meq) ( IVI ).

Optimal doses of magnesium in prevention cisplatin induced nephrotoxicity

cisplatin with hydration magnesium

The goal of this \[ type of study: intervential study is to compare between different doses of magnesium to prevent cisplatin induced nephrotoxicity.\] In 75 participant population with head and neck cancer recieved cisplatin it aims to answer are: • • optimal doses of magnesium as 3 groups each group take 1gm of magnesium then second group take 2gm of magnesium and finally third group take 3gm of magnesium Researchers will compare \[ 3 groups \] to see if \[ magnesium has effects in prevention cisplatin nephrotoxicity\].

This study aims to:

* Investigate the potential role of magnesium in prevention of cisplatin induced nephrotoxicity in patient with head and neck cancer.
* Determine the optimal dose of magnesium (Mg).

Study Design :

* This is a randomized, controlled, parallel, prospective clinical study included 75 patients with head and neck cancer presented and treated at Clinical Oncology Department Tanta University Hospital, Tanta.
* This study will be approved by Research Ethics Committee of Tanta University.
* Randamization will be carried out based on days of hospital admission.

Treatment Protocol :

• All patients will be scheduled to receive the standard treatment of head and neck cancer. Concurent chemo radio therapy (CCRT) consisting of radiotherapy, cisplatin (40mg / m²) by intravenous infusion) . This regimen will be repeated weekly for 7 cycles .

Patients will be classified into three groups:

* Group 1 (n=25): receive cisplatin with hydration 500 mg magnesium (8 Meq) .
* Group 2 (n=25): receive cisplatin with hydration 1000 mg magnesium (16 Meq).
* Group 3 (n=25): receive cisplatin with hydration 2000 mg magnesium (32 Meq). Blood and urine sample will be drawn before and after treatment (7 cycles ).

For all patients the following will be performed:

1. Full history and physical examination.
2. Demographic data (patient weight, ideal body weight (IBW) and Body surface area (BSA) determination).
3. Renal function testing ( blood urea nitrogen (BUN), serum creatinine (SrCr), BUN/SrCr ratio, estimated glomerular filtration rate (eGFR), sodium (Na) level and magnesium (Mg) level ).
4. Nephrotoxicity will be defined according to common terminology criteria for adverse events version 5.00 (CTCAE) (U.S. Department Of Health And Human Services.,2017).
5. Measuring health-related quality of life.
6. Laboratory, radiologically, and endoscopic examination for oncological diagnosis.
7. Estimation level of Urinary neutrophil gelatinase associated lipocalin (NGAL), Urinary kidney injury molecule - 1( KIM - 1) and Serum soluble Fasl at baseline and within five days of the last cisplatin dose administration.
8. Liver function tests (AST and ALT) before and after treatment (7 cycle).

Provision of Privacy :

* Privacy of all data is guaranated and there will be a file with code number for every patient and include all investigations.
* All patients will give their written informed consents.
* Data of all patients will be private and confidential.
* Any unexpected risks appeared during the course of the research will be reported to patients and ethical committee on time.

Comparative Study of Different Doses of Magnesium as a Protective Agent in Nephrotoxicity in Cancer Patients

Comparative Study of Different Doses of Magnesium as a Protective Agent in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer

Tanta University

clinical pharmacist

Heart and Blood Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Testicular Neoplasms

Hypogonadism

Lipid Metabolism Disorders

Metabolic Diseases

Eunuchism

Ischemia

Heart Diseases

Arteriosclerosis

Arterial Occlusive Diseases

Vascular Diseases

Gonadal Disorders

Endocrine System Diseases

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Testicular Diseases

Hormones

Hormone Antagonists

TCS cured with surgical resection and surveillance (surgical/surveillance, Arm 1)

TCS treat with one or more lines of cisplatin-based chemotherapy

TCS treat with one or more lines of cisplatin-based chemotherapy, and who have undergone bone marrow transplant

Lipid profile

Coronary artery assessment

Hormone levels for hypogonadism

Suparna Clasen, MD MSCE

Balaji Tamarapoo, MD PhD

Julie Lacy, RN

Suparna C Clasen, MD MSCE

Late subclinical cardiovascular disease in testicular cancer survivors exposed to cisplatin-based chemotherapy and bone marrow transplant

Testicular cancer (TC) is diagnosed in young adult males between 18-39 years old. There are late (≥10 years after treatment) atherosclerotic cardiovascular disease (ASCVD) events after cisplatin-based chemotherapy (CBCT) treatment in testicular cancer survivors (TCS), along with heightened rates of hypertension, dyslipidemia, diabetes mellitus, and metabolic syndrome. Early detection of ASCVD to direct preventive measures in young TCS is an unmet need as these patients typically fall short of traditional 40-45-year age-cut offs for ASCVD screening. ASCVD risk will be evaluated in TCS ≥ 10 years after treatment in three groups: 1)TCS exposed to CBCT, 2)TCS exposed to CBCT and bone marrow transplant (BMT), and 3)TCS cured with surgical resection/surveillance. The focus will be on detecting subclinical atherosclerosis in TCS using blood lipid biomarkers and advanced cardiac CT imaging.

Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors

Detection of Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors Exposed to Cisplatin-based Chemotherapy and Bone Marrow Transplant

HDL, LDL, Tg, Cholesterol, Novel Lipid biomarkers using blood draws

Coronary calcium score, coronary artery anatomy and plaque assessment using CT scans

Measurement of residual serum platinum levels

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Effects of Silymarin on Cisplatin Induced Nephrotoxicity in Upper Gastrointestinal Adenocarcinoma	NCT01829178	Upper GI Cancer Cisplatin Adver...	Silymarin Placebo chemotherapy	18 Years - 70 Years	Tehran University of Medical Sciences
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury	NCT02250872	Cancer Cisplatin Adver...	Gemigliptin Placebo Cisplatin	18 Years - 70 Years	Seoul National University Bundang Hospital
Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer	NCT03400709	Cisplatin Adver... Hearing Loss Ot...	N Acetylcystein... Placebo Oral Ta...	18 Years -	Hospital San Juan de Dios, Santiago
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury	NCT02250872	Cancer Cisplatin Adver...	Gemigliptin Placebo Cisplatin	18 Years - 70 Years	Seoul National University Bundang Hospital
Comparative Study of Different Doses of Magnesium as a Protective Agent in Nephrotoxicity in Cancer Patients	NCT05586009	Cisplatin Adver...	cisplatin with ...	18 Years - 65 Years	Tanta University
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors	NCT05611307	Testicular Canc... Survivorship ASCVD Coronary Artery... Lipid Disorder Hypogonadism, M... Cisplatin Adver... Bone Marrow Tra...	Lipid profile Coronary artery... Hormone levels ...	18 Years - 99 Years	Indiana University

Spots Global Cancer Trial Database for cisplatin adverse reaction