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Breast Cancer clinical trials

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NCT ID: NCT03420105 Completed - Breast Cancer Clinical Trials

Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep

PROSOM-K
Start date: January 5, 2018
Phase: N/A
Study type: Interventional

The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.

NCT ID: NCT03419741 Completed - Breast Cancer Clinical Trials

Brain Stimulation For Cancer Smokers

Start date: October 21, 2017
Phase: N/A
Study type: Interventional

Smoking cessation and relapse prevention represent and important opportunity to improve cancer survival rates, reduce the risk of cancer treatment complication, and improve the quality of life of patients with and survivors of cancer. Previous studies showed that repetitive TMS (rTMS) reduced cue craving to smoking and treat nicotine dependent smokers. Recently one study completed by our team demonstrated that 10 sessions of rTMS over the left dorsolateral prefrontal cortex (DLPFC) reduced cigarette consumption and cue craving, and also increased quitting rate on target quit date in nicotine dependent smokers. Thus, we propose conducting a controlled, double-blind trial comparing the effect of treatments of active rTMS and sham rTMS on cigarette abstinence days, cigarette consumption and smoking craving during a 7-days of quit attempt period in 20 nicotine-dependent patients with cancer. Specific aims are: Aim 1: Assess a feasibility of the rTMS for smoking cessation in cancer patients. Aim 2: Obtain preliminary estimates of whether one-week active rTMS of left DLPFC tends to be more efficacious than sham rTMS during a 7-days of quit attempt laboratory model period increasing abstinence days, and also decreasing cigarette consumption and cue-elicited craving in cancer patients with smoking.

NCT ID: NCT03419026 Completed - Breast Cancer Clinical Trials

Pregnant Exposure to Persistent Organic Pollutants

Start date: May 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

Breast cancer, the first female cancer, affects one in eight women in her lifetime. The increase and uneven distribution of its prevalence throughout the world cannot be fully explained either by the increase in life expectancy, or by genetic factors present in less than 10% of cases, or by early detection, or by the use of hormone therapy for menopause at certain periods of time. Numerous experimental and epidemiological arguments, as well as the increased risk of breast cancer in women after 50 years of age who were exposed in utero to Distilbene prescribed for their mothers in the 1950s to 75's, suggest the involvement of environmental factors involved in early development (nutrition, alcohol, tobacco, chemical pollutants) that may act as endocrine disruptors, estrogenomimetic or intervening on other nuclear receptors such as the However, the formal demonstration of the deleterious physiopathological role of such exposure comes up against methodological difficulties in epidemiological terms: first of all, the fact that correlation is sought at the time of the discovery of breast cancer when there are critical windows of exposure (fetal, perinatal, peripubertal and pregnant) and that persistent organic products or POPs, most often lipids, are present. The objective of this project is to correlate the per-gravidic exposure to POPs (dioxins, dioxinlike, polychlorinated bisphenyls, organochlorine pesticides and flame-retardant polybrominated derivatives) and the development, within 15 years of delivery, of breast cancer, taking into account the confounding factors of classical breast cancer risk (age, reproductive events, etc.). This project benefits on the one hand from a cord blood bank set up between 2002 and 2005 (6,242 samples) carried out at the Nice University Hospital and the Grasse University Hospital, during a PHRC and on the other hand from the cancer observatory / CRISAP of the PACA Corsica region, exhaustive to more than 92% since 2005, registers which will be cross-referenced and whose cancer cases (N) will be compared to controls. The assays will be carried out after purification, using high-resolution mass spectrometry gas chromatography coupling, the quantification being carried out according to the principle of isotopic dilution. They will be carried out by LABERCA in Nantes, the national reference laboratory of the French Health Agencies ANSES and INVS and also involved in various European projects. Concentrations related to blood lipids will be expressed in quartile and analyzed separately or combined with a cumulative score taking into account confounding risk factors for breast cancer and the geolocation of the initial and final residence in relation to the incinerator of the City of Nice (Department of Public Health CHU of Nice).

NCT ID: NCT03415646 Completed - Breast Cancer Clinical Trials

The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery

Start date: February 3, 2018
Phase: N/A
Study type: Interventional

Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.

NCT ID: NCT03409198 Completed - Breast Cancer Clinical Trials

Phase IIb Study Evaluating Immunogenic Chemotherapy Combined With Ipilimumab and Nivolumab in Breast Cancer

ICON
Start date: January 21, 2018
Phase: Phase 2
Study type: Interventional

Breast cancer is rarely curable after metastasis, and the therapeutic options are limited. Interestingly, the host immune response is strongly predictive for the effect of chemotherapy in subgroups of patients with breast cancer. The aim is to release the brake on the immune response by use of ipilimumab, which blocks CTLA-4 and may deplete regulatory T cells, combined with nivolumab (anti PD1). Importantly, it is possible that non-responders to nivolumab/ipilimumab (nivo/ipi) can be turned responders by use of immunogenic chemotherapy.

NCT ID: NCT03405519 Completed - Breast Cancer Clinical Trials

MR-guided RAdiotherapy to Breast With Dose Escalation to regionaL Lymph NodEs

MIRABELLE
Start date: December 18, 2017
Phase: N/A
Study type: Interventional

Radiotherapy to the breast and lymph nodes is routinely planned using CT scans. The introduction of magnetic resonance imaging (MRI) has the potential to better visualise the lymph nodes and so define a smaller treatment area or 'target'. This means that the dose delivered to the target could be increased without increasing the dose to normal tissues. The MIRABELLE study is designed to test if this is possible by recruiting patients diagnosed with breast cancer including lymph node disease. The investigators will ask participants to have a CT scan and an MRI scan before they have radiotherapy. The investigators will then plan radiotherapy using both these scans and compare the possible dose delivered to the lymph nodes using the MRI and CT defined lymph nodes. This will not affect the patient's future treatment.

NCT ID: NCT03402997 Completed - Breast Cancer Clinical Trials

Tissue Resistivity in Breast Cancer Patients

Start date: December 15, 2017
Phase:
Study type: Observational

The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.

NCT ID: NCT03402529 Completed - Breast Cancer Clinical Trials

Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.

Start date: November 28, 2017
Phase: N/A
Study type: Interventional

Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of malignant lesions in breast is required. Sometimes a supplementary MRI is therefore recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity and specificity. Size assessment using contrast-based modalities as CESM has also been shown to be significantly more accurate than using mammography. Prospective randomized studies using CESM are lacking. Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast cancer and choice of operation; partial mastectomy or mastectomy. A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized study. Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A supplementary examination with CESM will be performed. Preoperative extent of the malignant lesions are estimated with each modality and is later compared with the extent measured in post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT or endocrine therapy, breast volume and density is collected, as well as data of diagnosis (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression and Ki67 index. In this pilot study sensitivity and specificity for each modality is calculated. Multivariate analysis will be performed regarding influential factors. Pearson correlation coefficient will be calculated for each modality regarding size assessment of the malignant lesions in comparison with definitive PAD.

NCT ID: NCT03401086 Completed - Clinical trials for Breast Cancer Lymphedema

Comparison of Kinesiotaping and Pressure Garment on Women With Upper Extremity Lymphedema Following Mastectomy

Start date: February 4, 2017
Phase: N/A
Study type: Interventional

Breast cancer is a standout amongst the most widely recognized cancer among women. It is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems This study aimed to compare the effects of Kinesio taping and the pressure garment application on secondary lymphedema of the upper extremity and quality of life following mastectomy after breast cancer. Material and Methods: In this experimental study with pre and post-tests, 66 women with lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33) and pressure garment (PG) group (n=33). The KT group received Kinesio taping application, while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day through the study. All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life at baseline and end of intervention.

NCT ID: NCT03401034 Completed - Breast Cancer Clinical Trials

Influence of Lifestyle, Inflammatory Biomarkers, and Genetic Factors on Long-term Breast Cancer Prognosis

Start date: August 1, 2002
Phase: N/A
Study type: Observational

The MARIEplus study is a prospective cohort of breast cancer patients recruited into the MARIE (Mamma Carcinoma Risk factor InvEstigation) study, a population-based case-control study of breast cancer conducted in two German study regions, Hansestadt Hamburg and Rhine-Neckar-Karlsruhe (RNK) region. Participants were identified through participating clinics and the Hamburg cancer registry between January 1st, 2001 and September 30th, 2005 in Hamburg and between August 1st, 2002 and July 31st, 2005 in the RNK study region. Patients were aged 50-74 years at histologically confirmed primary invasive (stages I to IV) or in situ breast tumor (stage 0). Comprehensive information on demographic, socio-economic, and lifestyle factors was collected at multiple time points: at recruitment by a standardized face-to-face interview and at follow-up median 6 years as well as 11 years later using computer assisted telephone interview. Vital status was assessed in 2009 and again in 2015 via the population registries and causes of death were obtained from death certificates and coded according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10). Information on the clinical course was abstracted from medical records to verify clinical events either self-reported in follow-up interviews or reported by treating physicians. The studies were approved by the ethics committee of the University of Heidelberg and the University of Hamburg and conducted in agreement with the Helsinki Declaration. Written informed consent was provided by all participants at baseline and during follow-up. The primary objectives of this study are - To assess the association of modifiable lifestyle factors and personal factors, including BMI, diet, physical activity, tobacco and alcohol use, menopausal hormone therapy, socioeconomic status, with breast cancer survival, overall and according to tumor type, after accounting for established prognostic factors. - To examine the influence of genetic variants on breast cancer relapse and survival - To assess the association of lifestyle factors and their changes in the course of survivorship on subsequent breast cancer prognosis. - To assess the individual and combined association of inflammation/metabolic biomarkers as well as changes in their serum levels with subsequent breast cancer prognosis overall and according to tumor type. - To assess whether and to what extent the associations between breast cancer prognosis and lifestyle factors and/or their changes are mediated by circulating biomarker levels.