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

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Digestive System Diseases

Neuralgia

Depression

Depressive Disorder

Pain

Gastrointestinal Neoplasms

Digestive System Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Gastrointestinal Diseases

Quality of Life

Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma.

Yea-huei Kao Yang

Pain is one of the most common symptoms associated with cancer. The approach to pain management compresses routine pain assessments, utilizes both pharmacologic and nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain can be well controlled in the vast majority of patients if the algorithms of pain control are systematically applied, carefully monitored, and tailored to the needs of the individual patient.This study is aimed to assess the current pain managements in upper gastrointestinal cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled patients would also be assessed.

Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients

Pain intensities of participants would be assessed by BPI-SF at D1.

Changes in pain intensities of participants would be assessed by BPI-SF. The changes in pain would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.

Depression of participants would be assessed by questionnaires as mentioned at D1.

Changes in depression status would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.

Quality of life of participants would be assessed by questionnaires as mentioned at D1.

Neuropathic pain of participants would be assessed by questionnaires as mentioned at D1.

Changes in quality of life would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.

Changes in neuropathic pain would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.

National Cheng Kung University

Doctoral student

regorafenib

Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach

Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers

Patients had disease assessed by CT scans. Stable Disease is defined by any response better than Progression as defined by RECIST 1.1. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

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
Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients	NCT01718821	Pain Neuropathic Pai... Depression Quality of Life Upper GI Cancer		20 Years -	National Cheng Kung University
Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers	NCT02241720	Upper GI Cancer	regorafenib	18 Years -	University of Utah

Spots Global Cancer Trial Database for upper gi cancer