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NCT ID: NCT01968200 Active, not recruiting - Cancer Clinical Trials

Prevention of Anthracycline-induced Cardiotoxicity

ICOS-ONE
Start date: December 2012
Phase: Phase 3
Study type: Interventional

Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could also lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors (ACEi) and betablockers (BB) during the first elevation of cardiac troponin is able to reduce the incidence of heart failure (HF). ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The main objective is to assess whether enalapril started concomitantly to AC-containing treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed to selected patients showing laboratory evidences of injury after chemotherapy, during follow-up visits in 268 patients.

NCT ID: NCT01953159 Active, not recruiting - Breast Cancer Clinical Trials

Assessment of Paclitaxel-Induced Neuropathy

Start date: August 29, 2013
Phase:
Study type: Observational

The purpose of this study is to collect clinical data, blood samples, and self reported symptoms from patients that experience unusually severe neuropathy after treatment with paclitaxel. This data will be used to develop predictive markers for neuropathy. Blood samples will be used to create induced pluripotent stem (iPS) cells and eventually artificial nerve cells to be used to study neuropathy in the lab.

NCT ID: NCT01943864 Active, not recruiting - Cancer Clinical Trials

A Phase IIa Study of the MEK Inhibitor Trametinib Monotherapy in the Treatment of Biliary Tract Cancers

Start date: September 2013
Phase: Phase 2
Study type: Interventional

This is a Phase IIa, open-label, single-arm, multi-center study to evaluate the efficacy and safety of orally administered MEK inhibitor trametinib as the second line in subjects with advanced or metastatic biliary tract cancers (BTC) in Japanese population. The primary endpoint of this study is 12 week non-progressive disease (PD) rate defined as the percentage of subjects without progression at Week 12. As a sub-study, pharmacokinetics (PK) of four tablets of 0.5 milligram (mg) tablet, or one tablet of 2 mg tablet to achieve 2 mg daily regimen will be assessed to evaluate the pharmacokinetics of trametinib in Japanese population. Eligible subjects will be randomized to receive trametinib at the recommended Phase II dose of 2 mg every day as one 2 mg tablet or four 0.5 mg tablets on Day 1. From Day 2 until disease progression or withdrawal from the study treatment, all subjects will receive one tablet of 2 mg trametinib . Disease assessment will be performed every 8 week. Translational research is also planned to evaluate the potential blood or tumor tissue-derived biomarkers for biological activity, and sensitivity or resistance to treatment with trametinib .

NCT ID: NCT01871350 Active, not recruiting - Clinical trials for Cancer Patients Receiving Chemotherapy or Chemoradiotherapy

Nutrition Intervention During Chemotherapy

Start date: April 2013
Phase: N/A
Study type: Interventional

Weight loss and muscle wasting commonly occurs in patients with cancer, negatively influencing their quality of life, treatment response and survival. Weight loss has been reported as a side effect of chemotherapy treatment in cancer. Weight changes may be the consequence of energy imbalance and disturbances in protein metabolism (through different factors linked with chemotherapy), such as reduced caloric and protein intake (partly related to depression), poor treatment tolerance, hormonal alterations, systemic inflammation etc. This results in body composition modifications in favor of fat gain and/or lean body mass loss in early stage cancer and loss of both fat mass and lean mass in advanced cancer. Depletion of lean tissue in cancer patients is related to short survival, and decreased skeletal muscle mass and function may result in fatigue and inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity and increased mortality. Gains in muscle mass are difficult to achieve in cancer unless specific metabolic abnormalities are targeted. Recently, the investigators observed that essential amino acid mixtures (EAA) are able to induce protein anabolism in patients with stage III and IV non-small cell lung cancer. Previous experimental research and clinical studies in cachectic conditions (including cancer) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several disease states; however, weight and muscle mass gain was not present or minimal. Recent studies examining the effect of fish oil supplementation in relation to chemotherapy have been inconclusive but found potential beneficial effects on physical performance and increased efficacy of first-line chemotherapy in patients with non-small cell lung cancer. It is the investigators' hypothesis that supplementation with milk protein (containing essential amino acids) carbohydrate (CHO) mixture in combination with fish oil supplementation will target the metabolic alterations in cancer patients receiving chemotherapy, attenuating the negative effects of chemotherapy on gut function, muscle mass and muscle function, and cognition; and leading to reduced toxicity from chemotherapy.

NCT ID: NCT01843140 Active, not recruiting - Cancer Clinical Trials

Assessing Reproductive Outcomes in Young Female Cancer Survivors Through a National Fertility Preservation Registry

Start date: May 2011
Phase:
Study type: Observational

The FIRST project is a national fertility preservation registry for young women facing cancer treatments. The investigators will examine how different cancers and treatments affect the reproductive health of young survivors. This prospective cohort study seeks to recruit young women close to time of cancer diagnosis and treatment. Participants will answer a yearly questionnaire on their current health. A subset of participants will provide dried blood spots to measure reproductive hormones. The primary goal of the study is to determine the risk of infertility and time to pregnancy in young female cancer survivors.

NCT ID: NCT01839617 Active, not recruiting - Cancer Clinical Trials

Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery

PaNCS
Start date: May 7, 2013
Phase: N/A
Study type: Interventional

The aim of this study is to find which is the best nutritional strategy in cancer patients undergoing abdominal surgery regarding postoperative complications.

NCT ID: NCT01827514 Active, not recruiting - Cancer Clinical Trials

Studying Erythropoietin Receptor Presence and Function in Human Cancer Specimens

EPO-CAN
Start date: January 2013
Phase: N/A
Study type: Observational

Erythropoietin, EPO, is the main regulator and stimulator of bone marrow erythropoiesis, and is responsible for growth and differentiation of the erythroid cell lineage. Our team, in collaboration with partners (see below) has taken responsibility to study the presence, function and clinical significance of EPO-R in human cancer specimens. General Aim of the Proposed Project: To study EPO-R in human cancer specimens. Prepared slides from already taken preparations (specimens from Bone Marrow tests) will serve as the basis for that part of the work.Specimens will be taken from Breast cancer, Colon cancer, Lung cancer, Head & Neck cancer and from Lymph nodes biopsy (positive for lymphoma) The slides will be stained with anti-EPO-R antibodies (Abs).

NCT ID: NCT01715168 Active, not recruiting - Cancer Clinical Trials

A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer

Start date: October 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find the answers to the following research question(s): 1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same way in the body as the approved drug? ATI-0918 is believed to be a generic of Doxil/Caelyx and this is what the study is trying to prove. All people who participate in this study will receive the research study medication (ATI-0918) and Doxil/Caelyx in addition to best supportive care (treatment for symptoms). The study drug being tested in this study works the same as the FDA (government) approved drug doxorubicin HCl. ATI-0918 is a generic (the same) formulation of doxorubicin HCl being delivered (given to the patient).

NCT ID: NCT01666782 Active, not recruiting - Cancer Clinical Trials

Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy

IMMUNE
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.

NCT ID: NCT01579552 Active, not recruiting - Cancer Clinical Trials

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to empower women to improve their health in two very important areas: breast and heart health. This twelve-month study will compare two methods of informing participants about potential health risks and ways to stay healthy. The EMPOWER Study has been designed for adult women who were treated for a childhood cancer with chest radiation.