This is the largest study to date assessing cognitive changes over time in patients with breast cancer and lymphoma compared to individuals without cancer assessed at the same times as patients. We are also investigating biologic, clinical and psychological factors that may help understand risk to cognitive decline.
Fatigue is one of the most prevalent and distressing symptoms experienced by cancer patients and treatment options for cancer-related fatigue are limited. The goal of the current study is to conduct the first adequately-powered, randomized, double-blinded, placebo-controlled trial of bupropion for cancer-related fatigue. Positive results from the current study could improve fatigue and quality of life for large numbers of cancer patients.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, severe, dose-limiting, and tough-to-treat toxicity causing numbness, tingling, pain, and cramping in the hands and feet. URCC 19075 is a clinical trial in 120 patients with CIPN to test the effects of exercise on CIPN and to examine the role of the brain in CIPN, which has been understudied and may help transform our understanding of CIPN.
This study compares the effect of a clinician driven, aging-sensitive geriatric evaluation and management with survivorship health education (GEMS) program to usual survivorship care on patient reported physical function in older survivors of cancer. Survivors and their care partners in the GEMS arm receive tailored recommendations based upon their geriatric assessment and participate in a survivorship health education program twice a week for 4 weeks.
Insomnia is extremely prevalent and under-treated in cancer patients and survivors, nearly 80% of those diagnosed with cancer will have insomnia symptoms that interfere with health related quality of life and other aspects of functioning. The aim of this Phase III multicenter study is to evaluate the effectiveness of brief behavioral therapy for cancer related insomnia in reducing insomnia compared to healthy eating education control condition in 400 cancer survivors.
Immune checkpoint inhibitors (ICIs) use the body’s own immune response to fight cancer. Because immune response is generally stronger in patients of African ancestry (AA) than European ancestry (EA), AA patients may have more negative side effects from ICIs but may also respond better to them. In this study, we will follow a large group of AA and EA patients on ICIs over time in order to understand these racial differences and to see what other patient factors may predict these differences. The long-term goal is to ensure that all patients can benefit from new treatments for their cancer through appropriate management of side effects.
Use of androgen deprivation therapy (ADT), which causes near-total loss of testosterone, has increased dramatically in elderly prostate cancer patients over the last decade. ADT is associated with a significant increase in bone mineral density (BMD) loss and bone fractures, combined with a significant decrease in muscle mass. Vitamin D protects against BMD loss and fractures, but currently recommended supplementation levels (600-800 IU/day) are inadequate to protect against bone loss in a high risk population such as prostate cancer patients on ADT. High-dose vitamin D supplementation has shown promise, but results are limited. To address this, we are conducting a multi-center, phase III RCT in which 366 prostate cancer patients ≥65 years old starting ADT with vitamin D <27 ng/ml will be randomized to 1) 50,000 IU/week vitamin D or 2) a matching placebo for 52 weeks. All participants will receive a daily supplementation (800 IU vitamin D/1,000 mg calcium) to ensure a minimum of 100% RDA. The primary outcomes is the change in BMD, while secondary outcomes include changes in the clinically relevant outcomes of falls, balance, quality of life and fractures. If high-dose vitamin D was found to be efficacious, it would be a safe, low-cost, widely available, non- pharmacologic treatment that could drastically improve the prevention of ADT-induced bone loss and change clinical practice paradigms.
The LOTUS-CC trial is an observational study that aims to develop new diagnostic subtypes of cancer cachexia. Cancer cachexia is a debilitating syndrome that results in weight and muscle loss, weakness, fatigue, poor quality of life and reduced life expectancy. Many clinical trials for cancer cachexia therapies have been unsuccessful in the past and there are no FDA-approved treatments for cachexia. We hypothesize that one of the reasons for this lack of success is the broad diagnostic criteria and the prevailing thought that cancer cachexia is one disease entity with potential one-size-fits all therapies. Our study seeks to challenge this and aims to discover unique characteristics among different subtypes of cachexia so that clinical trials and treatment may be better tailored for individuals with cachexia in the future. Target enrollment for this study includes patients with advanced or metastatic colorectal, lung or pancreatic cancers. Participants do not need to be suffering from cachexia at enrollment to participate as we are hoping to learn from participants who never develop cachexia, those that develop cachexia during the course of the study, and those suffering from cachexia at the start of the study and may experience worsening, stability, or improvement.
Older adults with advanced cancer are at high risk for treatment toxicity. Geriatric assessment (GA) evaluates aging-related domains and guides management. We examined whether a GA intervention can reduce serious toxicity in older patients with advanced cancer receiving high risk treatment (e.g., chemotherapy).
Older patients with cancer and their caregivers worry about the effects of cancer treatment on aging-related domains (eg, function and cognition). Quality conversations with oncologists about aging-related concerns could improve patient-centered outcomes. A geriatric assessment (GA) can capture evidence-based aging-related conditions associated with poor clinical outcomes (eg, toxic effects) for older patients with cancer.
Despite chemotherapy-induced vomiting being very well-controlled by modern anti-emetic regimens, chemotherapy-related nausea remains a clinically significant issue for patients with cancer. However, current anti-emetic guidelines are based on control of vomiting, while there is very little data for control nausea. Our study will enroll patients on highly or moderately emetogenic chemotherapy and had significant nausea at their previous chemotherapy cycle despite receiving the appropriate ASCO-recommended anti-emetics. A total of 334 subjects with breast cancer will be randomized to receive either prochlorperazine (Compazine®), olanzapine (Zyprexa®), or placebo in addition to the appropriate ASCO-recommended anti-emetics. The primary outcome is average nausea levels on Days 1-4 after chemotherapy and we will also develop a prediction model that will include age, race, ethnicity, alcohol consumption, expectancy, anxiety, degree of nausea on the morning prior to treatment, and prior history of nausea. This study, with its focus on control of refractory chemotherapy-related nausea, will provide critical data for the creation of nausea-specific treatment guidelines.
This study investigates a possible anti-inflammatory intervention for cognitive changes in patients with cancer.
Chemotherapy-induced peripheral neuropathy is a side effect of chemotherapies used for common cancers, including breast, ovarian, and colorectal cancer. It can cause pain, numbness, tingling, cramping, and weakness. The purpose of this study is to test whether daily use of a convenient, wireless, home-based transcutaneous electrical nerve stimulation (TENS) can improve CIPN symptoms in cancer survivors.
URCC18110CD is designed to answer the question: “Is a Virtual Learning Collaborative (VLC) implementation strategy superior to a Technical Assistance (TA) strategy with respect to implementation, service, and patient outcomes for implementing the evidence-based ENABLE early palliative care program in NCORP practices?” In this study, NCORP practices receive either group (VLC) or individual (TA) support while implementing ENABLE. ENABLE focuses on living well, managing stress, communication of personal values and hopes for care, social support, and symptom management.
The primary objective of this study is to assess facilitators and barriers in the collection of sexual orientation and gender identity (SOGI) data at community oncology practices across the United States. We will first recruit 16 member practices of the URCC NCI Community Oncology Research Program (NCORP) Research Base. We will collect demographic information and complete 3 in-depth interviews with key informants at each practice, one each with a direct care provider (e.g., oncologist, nurse, advanced practice provider), an administrator, and a person responsible for patient data (e.g., front desk staff, IT specialist). We will use the Consolidated Framework for Implementation Research (CFIR) to guide the interviews and assess organizational- and provider-level factors that differentiate community practices that systematically collect SOGI data from those that do not. We will analyze de-identified transcripts of these interviews using traditional qualitative thematic analysis as well as configurational analysis.
Infusional chemotherapy drugs are among the most prevalent drugs in shortage in the United States and occur for some of the most used drugs, including those with curative intent. The goal of this project is to measure the magnitude of the effect of drug shortages on cancer care delivery using system-level measures from a minimum of 90 NCORP practices in an observational, prospective longitudinal survey design. Positive results from this study could provide context for future interventions, policy recommendations to FDA, or identification of best practices that oncology practices are using to avoid cancer care delivery problems from drug shortages.
The nationwide NCORP-conducted randomized GAP study (URCC 13059) evaluated if providing oncologists with a Geriatric Assessment (GA) could improve clinical outcomes and reduce treatment toxicity in adults aged 70+ with advanced cancer on chemotherapy. Sarcopenia, or skeletal muscle wasting, is a geriatric syndrome that is evaluated indirectly on the GA and has garnered an increase in research attention recently given its association with adverse outcomes in patients with cancer. To directly and most accurately evaluate sarcopenia, analysis of cross-sectional imaging (either Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)) is required. In 2020, we were able to secure NIH supplemental funding to assist NCORP sites to help locate, copy, and send or upload CT scan images and have these scans analyzed for muscle mass. This supplemental secondary analysis of URCC 13059 titled “Body Composition and Treatment Tolerability in Older Adults with Advanced Cancer” evaluated the relationship of skeletal muscle mass with treatment toxicity data (already collected). Muscle mass data can be obtained from the participants’ medical chart via examining films/CDs of CT abdomen and pelvis exams that were obtained by the participants’ oncologists as part of standard oncology care.
Older survivors of breast cancer are at increased risk of frailty, which is associated with a variety of negative health outcomes. It is unknown how frailty changes over time in survivors of breast cancer and whether there are biological markers that can predict the subset of survivors of breast cancer that will have worsening frailty trajectories after completing chemotherapy. In this study we aim to determine whether pre-chemotherapy accelerated DNAmage is associated with changes in frailty over time (Aim 1), the effect of chemotherapy on DNAmage in patients with breast cancer compared to non-cancer controls (Aim 2), and whether changes in DNAmage from pre- to post-chemotherapy is associated with changes in frailty from pre-chemotherapy to 6- months’ and 8 years’ post-chemotherapy (Aim 3). Aging specific epigenetic markers might be able to serve as a biomarker that can indicate which women with breast cancer are at increased risk of worsening frailty over time after completing chemotherapy. This proposal will fill critical gaps in our understanding of the trajectories of frailty with aging from before chemotherapy to 8-years after completing chemotherapy in survivors of breast cancer.
Cancer patients and survivors have disruptions in their 24-hour circadian rhythms, which may lead to worse co-morbidities such as insomnia, but it remains challenging to accurately measure human circadian rhythms. Our research uses blood tests to determine if a person’s circadian rhythm is healthy, and whether potential disruptions in circadian rhythms lead to these patients or survivors having worse insomnia symptoms. We are also studying whether interventions to improve insomnia, such as yoga or cognitive behavioral therapy, also improve circadian rhythms.
Systemic inflammation can contribute to cancer related fatigue and cognitive impairment in women who received chemotherapy for breast cancer. This study will test whether a polygenic score, which captures inherited variation in systemic inflammation, can predict these treatment side effects. If so, this score would be an attractive biomarker that could be measured cheaply, quickly, and accurately before a patient starts chemotherapy to help with selection of early preventative interventions and personalize care.