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Purpose: To evaluate the preventative effects of pregabalin on pegfilgrastim-induced bone pain in cycle 1. Because granulocyte colony stimulating factor (G-CSF) receptors are found at nerve endings which modulate the pain signal, blocking this with pregabalin is theorized to prevent the occurrence of this adverse effect. Participants: Patients will be at least 18 years of age with either a diagnosis of a non-myeloid hematologic malignancy scheduled to initiate a cycle of chemotherapy that requires prophylactic use of a G-CSF, or with a diagnosis of breast cancer scheduled to initiate dose-dense doxorubicin/cyclophosphamide chemotherapy or docetaxel/cyclophosphamide that requires prophylactic use of a G-CSF. Procedures (methods): This is a randomized (1:1), single center, placebo-controlled, double blind, crossover phase II study. The primary objective is to compare the proportion of patients who have an increase in pain score of ≥3 from baseline in cycle 1 between Arm A (pregabalin) and Arm B (placebo). In consultation with the treating physician, the PI will determine what day pegfilgrastim will be initiated in each eligible, consented patient. Pregabalin or placebo will begin 4 days prior to pegfilgrastim administration, and continue for 7 additional days starting the day of pegfilgrastim administration.
This study evaluates ADCT-502 in patients with Advanced Solid Tumors with HER2 Expression. Patients will participate in a dose-escalation phase (Part 1) and dose expansion (Part 2). In Part 2, patients will receive the dose level identified in Part 1.
HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.
Women with early stage breast cancer may experience difficulty falling asleep or staying asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia. Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of medications for sleep and an overall decrease in quality of life. The investigators have developed an internet-based website that is designed to help people manage symptoms typically experienced by breast cancer survivors, including insomnia, fatigue, pain and overall poor quality of life. The investigators want to learn whether this type of treatment can reduce chronic insomnia and improve the way subjects feel using both questionnaires and a special form of a wrist watch. This information may help the investigators better manage sleep difficulties in subjects who experience these symptoms after diagnosis of their breast cancer.
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.
This trial is a Phase II study using the "window-of-opportunity" design in which the treatment-free window between breast cancer diagnosis and surgical tumor resection is used to study the biological effects of the beta blocker propranolol .
The overall of this proposal is to test in community hospitals the utility of a 10-min magnetic resonance imaging (MRI) scan protocol combined with proprietary image analysis algorithms for detecting early cardiovascular (CV) injury during receipt of chemotherapy for breast cancer (BrC) and lymphoma. This technology provides health-care delivery systems with a time-efficient method to identify those at risk of a future CV event so that prevention can be implemented to prolong survival and reduce morbidity in cancer survivors.
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.