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NCT ID: NCT03453255 Recruiting - Chemotherapy Clinical Trials

DCHA as Postremission Therapy for AML With t(8;21)

Start date: January 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Acute myelocytic leukemia ( AML) is a highly heterogeneous group of malignant hematopathy. Chromosomal translocation with t (8; 21) (q22; q22) , about 10 ~ 15% incidence in AML and 40% incidence in the AML-M2 type of leukemia, is a karyotype that is considered to have a good prognosis. The National Comprehensive Cancer Network (NCCN) guidelines recommend that high-dose Ara-c regimens may benefit for patients, but with 30 to 40% relapse and serious risks on myelosuppression, infection and bleeding in high-dose Ara-c consolidation chemotherapy and more than 70% recurrence rate with (tyrosine kinase)KIT mutation. So the exploration of a relatively safe and efficient consolidation therapy is one of the difficult problems to be solved in the treatment of mitigatory t (8; 21) AML.

NCT ID: NCT03430999 Completed - Clinical trials for Chemotherapy Induced Peripheral Neuropathy (CIPN)

SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects

Start date: November 7, 2017
Phase: Phase 1
Study type: Interventional

Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects.

NCT ID: NCT03405324 Active, not recruiting - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Effect of tDCS of the Motor Cortex on Chemotherapy Induced Nausia and Vomiting

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

this work is looking for the effect of tDCS of the motor cortex on the chemotherapy induced nausea and vomiting in cancer breast patients

NCT ID: NCT03403712 Completed - Clinical trials for Chemotherapy-induced Nausea and Vomiting

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer

Start date: March 16, 2018
Phase: Phase 3
Study type: Interventional

Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion [test] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination [control]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.

NCT ID: NCT03373708 Not yet recruiting - Breast Cancer Clinical Trials

Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer

Start date: December 20, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Breast cancer is the most common female malignancy in the world, and the leading cause of cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the main prognostic factor for breast cancer patients. Breast cancer subtype was defined by ER, PR, HER2 and Ki67 status since the definition of intrinsic subtypes for breast cancer. Breast cancer which ER are positive have less aggressive and better long-term prognoses than other breast cancer subtype. Luminal B1 was definited as ER Positive, PR positive <20%, or Ki-67 ≥20% , and HER2-Negative. Although standard therapy to HR positive breast cancer is endocrine treatment, evidence reported that Luminal B1 breast cancers with lower PR expression are less sensitive to tamoxifen than luminal A breast cancers with higher PR expression, and the specific mechanism is not clear. We previously had a clinically analysed, and we found the Luminal B1 breast cancer had a significant proportion with 38%. Whether we need standard chemotherapy or chemotherapy based intensive endocrine therapy for those patients? In our research, we divided the patients with ER positive, PR negative, and HER-2 negative into two groups. One groups will be treated with 8 cycles of chemotherapy (EC×4-T×4). The other received 4 cycles of chemotherapy (TC×4) then will be given the intensive endocrine therapy (Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal patients). The primary endpoint is to assess disease-free survival (DFS) and overall survival (OS) in different regiments, the secondary endpoint is to assess the expression of female hormone levels. The correlation of the expression of female hormone levels with the clinical outcomes, so that the investigators could optimize adjuvant treatment regiment with luminal B1 breast cancer.

NCT ID: NCT03362177 Active, not recruiting - Clinical trials for Chemotherapy-induced Thrombocytopenia

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

RECITE
Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer

NCT ID: NCT03354741 Completed - Children Clinical Trials

Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children

NAUVOLA
Start date: May 23, 2019
Phase: N/A
Study type: Interventional

Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. At present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received. We propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.

NCT ID: NCT03348241 Completed - Clinical trials for Chemotherapy-induced Oral Mucositis

Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study

Start date: October 26, 2015
Phase: Phase 2
Study type: Interventional

This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy were divided into two groups; study "Gum Arabic" group (which received GA with chemotherapy) and control group (chemotherapy alone); and the participants were recruited to reach 190 patients in the study group and 184 patients in control group. This clinical trial was conducted in outpatient chemotherapy sections at Radiation and Isotopes Center of Khartoum. This study was designed to test the theory that say the chemotherapy-induced oral mucositis will significantly decrease after ingestion 30 grams as daily dose of Gum Arabic in a form of solution for six weeks during therapy.

NCT ID: NCT03344328 Completed - Multiple Myeloma Clinical Trials

Prevalence, Intensity and Consequences of Bortezomib-induced Neuropathic Disorders.

PREVIB
Start date: January 15, 2019
Phase:
Study type: Observational

Cancer-induced peripheral neuropathies (CIPN) remain a real problem in oncology (Balayssac et al., 2011). These CIPN are induced by certain classes of anticancer drugs such as taxanes (paclitaxel and docetaxel), platinum salts (cisplatin and oxaliplatin), alkaloids of Madagascar periwinkle (vincristine), bortezomib, thalidomide and eribulin (Balayssac et al., 2011; Vahdat et al., 2013). These CIPN essentially translate into sensory disorders such as paresthesia, dysesthetics or numbness. More rarely, these CIPN may be associated with motor or vegetative disorders (Balayssac et al., 2011). According to the recent meta-analysis by Hershman et al., no treatment can be proposed as a "gold standard" for preventing or treating CIPN (Hershman et al., 2014). As a result, oncologists reduce or stop doses of neurotoxic anticancer drugs because patients with CIPN have a marked deterioration in quality of life and co-morbidities such as anxiety, depression and sleep disorders (Hong et al., 2014; Mols et al., 2014). Therefore, understanding the pathophysiology of CIPN is essential to propose new therapeutic strategies. Among neurotoxic anticancer drugs, bortezomib remains relatively little studied in terms of pathophysiology compared to platinum salts or taxanes, while the neurotoxicity of bortezomib remains a limiting factor in treatment. Since 2012, the FDA and EMA have validated the administration of bortezomib subcutaneously instead of intravenously in order to limit the neurotoxicity of bortezomib (Minarik et al., 2015). Indeed, a large study (N=222) reported that subcutaneous administration of bortezomib allowed the same therapeutic efficacy to be maintained while improving the safety profile and in particular limiting peripheral neuropathies (CIPN all grades: 38% vs. 53%, p=0.044, grade> 2: 24% vs. 41%, p=0.012 and grade> 3: 6% vs. 16%, p=0.026) However, a recent retrospective study (N=446) reports that the prevalence of bortezomib-induced peripheral neuropathies after subcutaneous administration remains relatively high: all grade: 41%, grade> 2: 18%, grade> 3: 4%, and above all that this prevalence is not different between subcutaneous and intravenous routes (Minarik et al., 2015).

NCT ID: NCT03343847 Withdrawn - Clinical trials for Chemotherapy-induced Thrombocytopenia

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.

Start date: January 27, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of lymphomas measured by the ability to administer on-time, full-dose chemotherapy.