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Breast Cancer clinical trials

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NCT ID: NCT03625635 Active, not recruiting - Breast Cancer Clinical Trials

Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment

Start date: September 14, 2015
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of a 6-mo individualized and specialized food-based nutrition intervention program in breast cancer patients' body composition, metabolism and antioxidant activity associated with micronutrients, during antineoplastic treatment. It is a quasi-experimental prospective follow-up study of women with primary diagnosis of invasive breast cancer in Sonora, Mexico. Conducted between September 2015 through July 2018. The Ethics and Research Committees of The Oncology State Centre and the Food and Development Research Centre, have approved the study's protocol and procedures. At baseline, all participants must sign an informed consent form and answer an oral interview, including self-reported questionnaires, for their nutrition record. At the beginning and 6-mo after, participants will be weighed during the morning in a digital scale and height will be measured using a digital stadiometer. Body mass index (BMI) will be calculated and classified according to the World Health Organization criteria. Waist and hip circumferences will be measured with a metal tape, according to the protocol of the International Society for the Advancement of Kinanthropometry (ISAK), by a certified anthropometrist. Body composition components will be measured in a dual-energy x-ray absorptiometry (Hologic Corporation 4500 Waltham, MA) by total body, L1-L4, and femur neck scans. Blood samples will be drawn by a certified phlebotomist using sterile equipment and aseptic techniques. Breast cancer patients' total energy expenditure will be estimated using an algorithm for Mexican population. Diet plans and recommendations will be based on the individual's nutritional status, dietary habits, symptoms and treatment side-effects, socioeconomic and cultural preferences; as well as the WCRF/AICR guidelines adapting 1.5g/kg/d of dietary protein to avoid sarcopenic obesity and considering a caloric restriction (500-1000 kcal/d), when required. The individualized nutrition intervention program will be based on the macronutrient meal-equivalent menu method, and standard food servings will be based on the Mexican Food Equivalent System. To guarantee that the obtained content for each macronutrient (g/day) meets the theoretical calculations, protein ±1g/d, total fat ±1g/d, carbohydrates ±2g/d and energy ±15 kcal/d variations will be accepted. Breast cancer patients follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian, unto 6-mo are completed, and initial measurements will be repeated. The differences in body composition determinants will be analyzed using paired Student's t-test analysis for each variable. A two-tailed P-value of 0.05 or less will be considered significant. Retinol, tocopherol and carotenoids determination will be performed using HPLC. Serum will be thawed and retinol will be extracted using chloroform:methanol (3:1) and hexane, extracted layers will be combined and then evaporated to dryness under a soft stream of nitrogen. Samples will be re-suspended in ethanol before injecting onto the HPLC using a YMC C-30 column (30 cm length, 4.6 mm internal diameter, 3 µm particle size and 100 mm pore size). The HPLC system is an Agilent 1200 with UV-Vis and PDA detectors. Commercial standards and internal standards will be used to assess concentration and extraction efficiency, respectively. Additionally, the investigators will use a standard NIST serum (National Institute of Standards and Technology; Gaithersburg, Maryland USA). The cut-off point for vitamin A deficient status will be set at < 1.05 ╬╝mol /L. The plasma antioxidant capacity will be determined by the trolox-equivalent antioxidant capacity test (TEAC) and oxygen radical absorbance capacity assay (ORAC). For both assays, results will be expressed as millimoles of Trolox equivalents per liter. The effect and their interaction on the response variables will be determined by ANOVA. Tukey's test will be used for the comparison of the means. Values of p<0.05 will be accepted as statistically significant. Human inflammatory cytokines and chemokines will be analyzed by using a panel of 12 pro-inflammatory cytokines as a conventional ELISA protocol all at once under uniform conditions. The cytokines and chemokines represented by this array will be IL1A, IL1B, IL2, IL4, IL6, IL8, IL10, IL12, IL17A, IFNg, TNFa, and GM-CSF. Plasma activities of both enzymes, glutathione peroxidase (GPx) and superoxide dismutase (SOD) will be determined in baseline samples and after 6-mo, by using an ELISA (enzyme-linked immunosorbent assay) based upon a sandwich assay principle and can be used to detect levels of SOD as low as 0.066 ng/mL and 1.56 ng/mL for GPx.

NCT ID: NCT03624088 Active, not recruiting - Breast Cancer Clinical Trials

CBPR - BRCA Genetic Testing Among Orthodox Jews

Start date: March 13, 2018
Phase: N/A
Study type: Interventional

This study evaluates a web-based decision aid, named RealRisks, in promoting genetic testing intention among Orthodox Jewish women. 50 Orthodox Jewish women will take a baseline survey, self-administer the decision aid, and then complete two more surveys: one within one month of completing the decision aid and one at 6 months after completing the decision aid.

NCT ID: NCT03616626 Active, not recruiting - Breast Cancer Clinical Trials

Whole Breast Irradiation vs Twice Daily vs. Once Daily Accelerated Partial Breast Irradiation

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

This is a randomized phase III trial in women with invasive carcinoma of the breast with negative axillary nodes treated by Breast Conserving Surgery (BCS). Eligible, patients will be randomly allocated to receive radiotherapy of 3 Dimensional Conformal Radiation Therapy (3DCRT) Whole Breast Irradiation (WBI) 50 Gray (Gy) in 25 daily fractions over 5 weeks or Accelerated Partial Breast Irradiation (APBI) 38.5 Gy in 10 daily fractions of 3.85Gy over two weeks or 38.5 Gy in 10 twice daily fractions of 3.85Gy over one week. Patients will be followed at 6, 12, 18 and 24 months post randomization. Cosmetic outcome will be measured using photographs and evaluated by a panel of trained radiation oncologists. Radiation toxicity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

NCT ID: NCT03611543 Active, not recruiting - Breast Cancer Clinical Trials

Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

Start date: October 2016
Study type: Observational

The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle. This is a study that will be performed with x-ray imaging and will be used to determine if an overall reduction in pain can be appreciated in patients without loss in image quality as compared to the current standard mammogram. Another benefit of the curved paddle may be an increase of perceivable and measurable tissue capture.

NCT ID: NCT03606616 Active, not recruiting - Breast Cancer Clinical Trials

Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients

Start date: August 1, 2015
Study type: Observational [Patient Registry]

In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). We conducted a prospective single-arm study to confirm the applicability of the Z0011 criteria to Chinese patients with breast cancer.

NCT ID: NCT03586583 Active, not recruiting - Breast Cancer Clinical Trials

Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing

Start date: June 30, 2018
Phase: N/A
Study type: Interventional

The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).

NCT ID: NCT03562390 Active, not recruiting - Breast Cancer Clinical Trials

Irinotecan for Advanced and Metastatic Breast Cancer

Start date: April 1, 2017
Phase: Phase 2
Study type: Interventional

This trial aims to evaluate the safety and efficacy of third-line or later irinotecan treatment for locally recurrent or metastatic breast cancer among Chinese patients who have received at least two regimens containing anthracyclines and taxanes.

NCT ID: NCT03541863 Active, not recruiting - Breast Cancer Clinical Trials

Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients

Start date: October 10, 2017
Study type: Observational

What Comes After Fulvestrant? A Real World Multicenter Retrospective Study-Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients in China.

NCT ID: NCT03482401 Active, not recruiting - Breast Cancer Clinical Trials

Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.

NCT ID: NCT03472794 Active, not recruiting - Breast Cancer Clinical Trials

Adaptation of a Knowledges Exchange Portal Between (KEP) Healers and Patients : Obstacles and Sources to KEP Use for Breast Cancer Women

Start date: January 31, 2018
Study type: Observational

The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway. The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context