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At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to randomize 30 female breast cancer survivors (history of breast cancer stages I [> 1 cm], II, or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in > 8 hours a day of SB) and inactive (engage in < 100 min/wk MVPA) to one of three, 3-month conditions: 1. lifestyle intervention (Lifestyle) (increase MVPA to > 200 min/wk); 2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to > 200 min/wk and reduce SB by 2 hrs/day); or 3. weight management education materials provided via mailed newsletter (Newsletter). Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie [1200-1500 kcal/day], low-fat [<30% calories from fat]) prescription that emphasizes intake of fruits, vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting activity and diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis that have been found to be positively related to SB and/or adiposity); diet; body composition; and fitness.
The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other performance measures.
The acute pain care, in particular after breast cancer surgery must be early and quickly effective, because a severe postoperative pain increases the risk of chronic pain and exposes to a risk of important embarrassment for the realization of simple daily movements. Associated to conventional analgesics administered by systemic way, a local anesthesic (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the surgical unit by the surgeon at the end the surgical procedure. Besides the control of the postoperative acute pain, the local anesthesic could intervene in the prevention of the chronic pain, the early recovery, the reduction of the neuropathic pains and the decrease of needs in morphine after mastectomy. The duration of hospitalization being lower than 48 hours for this type of surgery, the investigators envisage an immediate follow-up in the Units of Care then at home, what will require a training of the hospital actors and at home (patient, family, visiting nurse, general practitioner). Although proposed for several years, the CCP after breast surgery is still a little spread technique and few works had evaluated the pain at rest and at mobilization after mastectomy, the early rehabilitation, and to spread its use towards home, that is why we propose a randomized double-blind study ropivacaine / placebo in patients after mastectomy.
Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.
This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy.
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects and cosmetic results.
The goal of this clinical research study is to learn if metformin can help to control nerve damage (loss of motor or sensory function) that may be caused by treatment with paclitaxel in patients with breast cancer. In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
This prospective, single center, phase II study is to evaluate the efficacy and safety of bicalutamide as a treatment in androgen receptor (AR)-positive metastatic triple-negative breast cancer (mTNBC) patients.
The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for biopsy after recall from screening and diagnostic work-up. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance measures.
Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure widespread accepted in the treatment of different tumors, especially in the liver but its benefit is not yet well-known in breast cancer. Our main objective is to evaluate the usefulness of RFA in < 2cm malignant breast tumors to reduce the proportion of positive margins. Methodology: The investigator propose a single-center, single-blind, phase I and II randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the potential adverse effects in three stages: initial,intermediate and final. Phase II: Randomized clinical trial, 2 parallel groups with 37 patients in each one. Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group: conventional surgery with lumpectomy. The number of positive margins in both groups, and the need of extending margin resection will be assessed intraoperatively. Inclusion criteria: women >40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique, visible by ultrasound, smaller than 2cm and located > 1 cm from the chest wall and the skin. Patients will be followed up for a period of two years to assess cosmetic result, short -term and long -term complications and recurrences. Expected results: The "cool-tip" (cluster) ablation method reduces by at least 30% the risk of intraoperative extensions for positive margins during lumpectomy compared to conventional surgery in breast tumors with a diameter < 2 cm. Therefore this procedure may reduce the risk of second surgeries and the removed volume of tissue.Consequently the final cosmetic result should be improved.