46 Clinical Trials for Various Conditions
Psychosocial distress is common in patients with an oncologic diagnosis, with anxiety being present in almost 20-30% of the patients.\[1, 2, 10\] Mindfulness exercises have shown to reduce this distress.\[4, 5\] Recently, the implementation of a 60-second mindfulness-based intervention has shown to have momentary effects on pain, anxiety, depression and anger in orthopaedic upper extremity patients.\[9\] However, its lasting effect after the single intervention was not evaluated. Nonetheless, because the intervention is not time consuming and is easy to implement it may benefit orthopaedic oncology patients in their pre-operative coping. The implementation of a 60-second mindfulness-based intervention has shown to have momentary effects on pain, anxiety, depression and anger in orthopaedic upper extremity participants. In this research study, the investigators are studying a 60-second interactive personalized acceptance-based mindfulness exercise
This study is being done as the doctor investigators would like to lessen the amount of blood transfusions given to patients. Patients who receive blood transfusions have a greater chance of developing complications after surgery. There is a device called the Cell Saver that allows the doctors to process blood that is lost during surgery and return it to the patient. This lessens the amount of transfused blood the patients receive. This device is not used for patients undergoing surgery for muscular skeletal tumors.The investigators are not sure whether tumor cells are present in the blood which is lost during the course of an operation like yours. The goal of this study is to see if we lessen the amount of blood transfusions given to patients who may have tumor or cancerous cells present in their blood. One way to do this is to test the blood that is circulating in your veins and also to test the blood which is lost during the course of your operation
Researchers at St. Jude Children's Research Hospital are looking for more effective ways to deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the study is to improve local control of musculoskeletal tumors with image-guided radiation therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to precisely define tumor location and to carefully plan radiation treatment. This approach allows doctors to deliver highly conformal radiation therapy to the tumor while protecting nearby healthy normal tissues.
This study intends to determine if any correlation exists between administration of TXA or not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood loss and blood transfusion rates.
This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.
This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent's Riverside. This may help doctors better understand and/or treat others who have genetic mutations.
This is a research study to compare the efficacy of aspirin (acetylsalicylic acid) and pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic compression devices in preventing deep vein thrombosis in patients with pelvic and lower extremity malignant tumors and undergoing surgery. Pneumatic compression devices are also known as sequential compression devices and are inflatable compression sleeves that are placed around patient's legs to reduce the risk of clot formation deep vein thrombosis. Pneumatic compression devices are made of a soft material that wraps around the lower leg and periodically squeeze the calf. A deep vein thrombosis is a blood clot. Most hospitalized patients wear these as a preventive measure. Pneumatic compression devices alone are not sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in patients with musculoskeletal tumors which have determined whether one drug is better than another. The knowledge gained from this study will determine whether aspirin and pneumatic compression devices is the same or better than enoxaparin and pneumatic compression devices in preventing deep vein thrombosis in this patient population and may result in fewer wound and bleeding complications
RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer that has not responded to previous therapy.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin in treating children who have refractory solid tumors.
OBJECTIVES: I. Identify and characterize the gene causing diaphyseal medullary stenosis with malignant fibrous histiocytoma of the bone. II. Determine the clinical manifestations of this disease in these patients.
Treatment of hormone receptor (HR)-positive breast cancer with Aromatase Inhibitors (AIs) can lead to associated musculoskeletal pain and may cause patients to discontinue important treatment. This is a randomized controlled trial assessing the affect of Vitamin B12 on AI-associated joint pain and other outcomes. Participants will be randomly assigned 1:1 to treatment or control arm. The primary objective of this study is: -To assess whether daily oral Vitamin B12 decreases average joint pain in women with AI-Associated Musculoskeletal Symptoms Secondary objectives include: * To investigate whether daily vitamin B12 improves functional quality of life * To explore the impact of treatment on serum inflammatory cytokine levels (C- reactive protein) between baseline and various points in treatment.
Aromatase inhibitor therapy has become a standard adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. Up to 50% of postmenopausal breast cancer survivors exhibit significant aromatase inhibitor musculoskeletal symptoms, defined as severe joint pain and stiffness. Aromatase inhibitor musculoskeletal symptoms in turn has a negative effect on the women's physical function and quality of life, leading to discontinued aromatase inhibitor therapy and causing significant social and economic burden. Given aromatase inhibitor musculoskeletal symptoms' profound effects, the management of aromatase inhibitor musculoskeletal symptoms is an essential component in cancer care. The investigators propose to test auricular point acupressure- -an innovative, non-invasive, nonpharmacologic, and low-cost intervention- -to manage aromatase inhibitor musculoskeletal symptoms in breast cancer survivors. Auricular point acupressure applies an acupuncture-like stimulation to ear acupoints without using a needle (i.e., seeds are taped to the acupoints) to treat illness/symptoms. Auricular point acupressure is particularly well suited for current challenges of unmet aromatase inhibitor musculoskeletal symptoms management. The investigators propose a randomized controlled trial to (1) determine the efficacy of auricular point acupressure in relieving aromatase inhibitor musculoskeletal symptoms, and (2) examine the inflammatory signaling of auricular point acupressure effects in breast cancer survivors treated with aromatase inhibitor. The investigators will also measure psychological, behavioral, personal, and social factors that may moderate or mediate the effects of auricular point acupressure. The investigators also believe inflammatory cytokines may partially explain the mechanism of action of auricular point acupressure for improved aromatase inhibitor musculoskeletal symptoms and physical function, and plan to measure these. This study will identify a novel approach to manage aromatase inhibitor musculoskeletal symptoms in postmenopausal breast cancer survivors, with minimal side effects. If successful, the paradigm of pain management will shift from a traditional medical model to a larger integrative medicine and patient-management paradigm to avoid unnecessary evolution towards prolonged disability.
The purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.
This is a randomized, double-blinded trial of self-acupressure to examine the effect of treatment on aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) in postmenopausal women with breast cancer. Acupressure is similar to acupuncture, but uses pressure rather than needles to stimulate specific points on the body. Acupressure involves applying mild to moderate physical pressure using your fingers, or an assistive device, to these points to try to bring about a physiological change in your body, in this case relief from joint pain and stiffness. The investigators will also examine effects of acupressure on other symptoms that commonly develop in AI-treated patients. In addition, changes in stool microbiome with acupressure treatment will be examined in an exploratory way to obtain preliminary information about the effect of acupressure on the gut microbiome in this condition.
The purpose of this study is to compare the effect of low intensity vibration (LIV) delivered for 10 minutes twice daily for 12 months on skeletal muscle function, in terms of energetic capacity measured by power generation on a stationary bicycle, among patients with early stage breast cancer planned to initiate aromatase inhibitor therapy who do not currently participate in regular exercise, compared to a wait- listed control.
Both Tart Cherry and Omega 3 FAs have better side effect profiles compared to other commonly used medications for AIMSS, such as nonsteroidal anti-inflammatories, steroids, and serotonin norepinephrine reuptake inhibitors. Additionally, in our clinics we often find that patients tend to be more receptive to taking a supplement as opposed to an additional medication. Further, both Tart Cherry concentrate and fish oil have beneficial properties for helping with joint stiffness in general, in addition to other health issues like insomnia. There is preliminary evidence in mouse models that when given together, these supplements may have an even greater anti-inflammatory effect than when taken separately14. Although to our knowledge, no human studies have tested this hypothesis. This study has been designed to test the hypothesis that Tart Cherry and fish oil when given in combination over a 12-week period could produce beneficial changes in joint function when compared to Tart Cherry or fish oil in isolation in an obese breast cancer population experiencing AIMSS. Secondary outcomes to be assessed include pain, functional performance, quality of life and cognition.
This study evaluates the effectiveness of a cognitive behavioral multicomponent treatment program in improving pain, mood, and functioning while reducing medication non-adherence in breast cancer patients with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS).
Aromatase inhibitors (AIs) are commonly used for post-menopausal women with hormone-positive breast cancer. Compared to tamoxifen, AIs improve breast cancer recurrence rates and lower 10-year breast cancer mortality. Unfortunately, nearly 2 out of 3 women with estrogen-receptor positive breast cancer treated with AIs experiences AIMSS, such as arthralgia, joint stiffness, and bone pain, and 30% of women with AIMSS report severe pain. AIMSS leads to poor adherence with therapy and discontinuation of therapy in up to 20% of patients. Despite the large number of women affected, current therapeutic interventions have shown only limited efficacy in improving AIMSS. Therefore, the presence of AIMSS may negatively impact breast cancer recurrence and survival. In this current trial, the plan is to utilize topical cannabinoid creams from Vireo Health that have been tested for potency and purity. Two distinct products with different THC/CBD ratios will be provided to patients at no cost; a) a THC-dominant cream (Red XS Balm with 375mg/jar and \<20mg of CBD) and b) a CBD-dominant cream (Violet Balm with 2210mg CBD/jar and \<0.3% THC). The study will explore the feasibility of doing larger, placebo controlled trials by first ensuring adequate patient interest, acceptable tolerability/safety of cream utilization, and preliminary efficacy measures. All patients completing assessments through day 14 will be allowed to choose either Red XS or Violet creams for an additional 2-week extension period.
The objective of this proposed project is to determine which local anesthetic is more efficacious for use in soft tissue tumors: Exparel (liposomal bupivacaine) or a cocktail of Ropivicaine, Epinepherine, Ketolorac and Clonidine. This study will examine patients' post-operative pain levels as well as their narcotic consumption after removal of a soft tissue tumor while hospitalized and then twice daily through postoperative day 14.
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
This study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.
Breast cancer is one of the most prevalent cancers with 207,090 new cases of breast cancer and 39,840 deaths in women predicted for 2010 in the United States. Aromatase inhibitors (AIs) are used as first-line adjuvant therapy for postmenopausal women with early stage breast cancer. The effectiveness of current therapy is widely recognized to be compromised by poor compliance because of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), a syndrome that affects up to 40-50% of women who take these medications. The syndrome that was not recognized during the registration trials for this class of drugs, it can lead to discontinuation in up to 24% of women over 2 years. Knowledge that can be used to prevent discontinuation of these important agents because of severe AIMSS is urgently needed.
This pilot clinical trial studies questionnaires in identifying arms, shoulder, and neck (upper extremity) function and quality of life after treatment in patients with breast cancer. Patients may experience arms, shoulder, and neck impairments that negatively affect their functioning and quality of life after cancer-related treatment. Studying upper extremity function and quality of life in patients after breast cancer treatment may help doctors determine the prevalence and severity of long-term functional impairments and the relationship between the perception of impairments due to breast cancer treatment and its' impact on quality of life.
Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. This observational study is designed to collect patient-reported outcomes and serial serum samples in order to investigate potential etiologies of this bothersome toxicity.
This randomized clinical trial studies genetics in predicting risk of bisphosphonate-related osteonecrosis of the jaw in patients with cancer receiving zoledronic acid. Zoledronic acid is an anti-resorptive drug used as part of cancer treatment. A serious side effect of these drugs is death of the jawbone, commonly called bisphosphonate-related osteonecrosis of the jaw (BRONJ). Genetic research may help doctors understand risk factors for BRONJ or who is more likely to get BRONJ and why.
E1Z11 is a study to determine whether certain genetic information can predict which breast cancer patients will discontinue treatment with aromatase inhibitors (AIs) due to the development of musculoskeletal symptoms (MSS). Women with stage I-III breast cancer who are prescribed the aromatase inhibitor anastrozole as treatment may join.
Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity. Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.
RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.
RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal symptoms in women receiving hormone therapy for breast cancer. PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast cancer receiving letrozole.
Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms are commonly reported with AI treatment,however, we do not have consistent methods to measure these symptoms prospectively. This gap in our knowledge inhibits the ability to test and develop treatments for AI-associated musculoskeletal symptoms. This pilot study will evaluate functional tests and standardized instruments for their ability to prospectively assess musculoskeletal symptoms in women being treated with AIs for breast cancer.