66 Clinical Trials for Various Conditions
Pancreatic cysts (A cyst is a thin walled cavity containing fluid) were rarely reported previously, but have been on a rise due to advanced imaging for evaluating pancreatic lesions or other medical reasons has increased detection of pancreatic cysts. Study shows transformation of pancreatic cysts to be 10.8 for every 100,000 women and 13.8 for every 100,000 men. Pancreatic cysts are divided in two groups; serous and mucinous. Serous cysts are thin walled cysts and are not associated with precancer. On the other hand, mucinous cysts have a tendency to progress to pancreatic cancer. Radio frequency ablation (RFA) is an alternative method used for patients who could not or decided to not undergo surgical removal of the cyst. This study is a standard of care study and no changes in regards to the procedure scheduled with the physician will be changed.
Background: Despite advances in symptom management, children undergoing cancer treatment or receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological distress. Pharmacologic treatments of symptoms can cause side-effects. Patients, parents, and clinicians have expressed interest in including non-pharmacologic approaches to improve symptom management. Acupuncture/acupressure is a promising adjunctive therapy to usual care. More evidence is needed from well-designed trials with larger samples and rigorous designs in order to make definitive recommendations about the routine inclusion of acupressure among pediatric patients being treated for childhood cancer or receiving a HSCT. Design and Methods 100 dyads (one child with one parent/caregiver) will be randomized 1:1 into 2 study arms (50 children in each arm). Arm A participants will be offered usual care and professional acupressure five times weekly (15-20 minute sessions) and a parent/caregiver will be instructed in acupressure delivery for the child as symptoms arise. Arm B participants will receive usual care alone. (At the study end, Arm B parents will be offered acupressure instructions.) Children will be enrolled for \~30 days which can occur with one month of continuous hospital-based treatment or two months of intermittent hospital-based treatment (inpatient or regular outpatient treatment). Parent and child participants will receive a follow-up interview one month after completion of the intervention (Arm A) or the final symptom assessment (Arm B). Significance This is the first study to evaluate the effectiveness and safety of an acupressure intervention to decrease treatment-related symptoms in 100 patients in treatment for a childhood cancer or receiving a chemo-therapy based HSCT.
The goals of the study are to determine the efficacy of clonidine in the treatment of children with neurocognitive sequelae following the therapy of long term malignancies. In addition, the study hopes to determine the long-term effect of clonidine on children's academic and psychosocial function.
This phase II trial studies how well nivolumab works in treating patients with acute myeloid leukemia that has decreased or disappeared but may still be in the body (remission), and is at high risk for returning (relapse). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
This study is being done to find out if patient blood samples can be used to perform individualized modeling of cancer therapy-related side effects.
This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy.
The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer and neuropathy from cancer treatments. The investigators are interested to find out if the participant have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. Investigators are also interested to see if the participants have any difficulty with doing two activities at the same time, such as walking and texting.
The purpose of this study is to find out if adding vericiguat to standard treatment for cancer therapy related cardiac dysfunction (CTRCD) is more effective than standard treatment alone. The addition of vericiguat to the usual treatment could help improve cardiac function, but it could also cause side effects. This study will help researchers find out whether this different treatment is better, the same as, or worse than the usual approach.
The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.
Cancers located in the upper aerodigestive tract of the head and neck region present unique management challenges due to the crucial functions in this anatomic region along with its anatomic density. As such, cancers themselves and the actual treatment can affect these functions. Of these, the ability to effectively and safely transport a swallow bolus from the oral cavity to the esophagus is particularly important. This consideration has in fact been a major source of debate regarding the optimal management for head and neck cancers as both oncologic-effective and function-preserving therapies are desired. Accomplishing this therapeutic goal has been elusive and can be attributed to a lack of tools that effectively and longitudinally evaluate swallow function over the course of a treatment and in follow-up. As such, investigators surprisingly lack a clear understanding of the natural history of treatment -related swallow dysfunction (dysphagia) regardless of the treatment modality. As such, understanding the prevalence of this significant complication is in fact not well established. Understanding the true prevalence of treatment-related dysphagia is in fact critical to establish as it will help guide decisions as to whether or not treatment strategies require modification including de-intensification of treatment that is receiving considerable attention for favourable prognosis patients associated with the human papillomavirus (HPV). To address this problem, winvestigators hypothesize that the quantitative and validated patient-reported outcome (PRO) instrument, the Sydney Swallow Questionnaire (SSQ), can be an effective tool to longitudinally measure swallow function to determine the natural history of head and neck cancer treatment-related swallow dysphagia. The SSQ is particularly well suited for longitudinal evaluation of swallow function as it quantifies various aspect of patient-perceived swallow function in contrast to other swallow PROs that measure the impact of swallow function on quality of life domains. To determine the two-year prevalence of dysphagia, investigators will employ a multi-institution prospective study design using our Oncospace® web-portal to facilitate secure prospective data curation and analysis that will include evaluations before, during and following standard of care definitive cancer treatment for a total of 36 months in the follow-up period.
Physiological Biomarkers of Cancer Treatment Related Fatigue in Women with Breast Cancer.
The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.
A 24-week, (two 12-week stages), randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of crofelemer in providing prophylaxis of diarrhea in adult patients with solid tumors treated with targeted cancer therapy-containing treatment regimens. Diarrhea grading will be done according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Patients will be randomized 1:1 to placebo or crofelemer and will be stratified by the type of targeted cancer therapy and the tumor type. Placebo and/or crofelemer will be dispensed at Visit 1/Day 1 with the concurrent start of the targeted cancer therapy regimen. The initial Stage I double-blind placebo-controlled primary treatment phase will occur over a 12-week period to accommodate approximately 3 cycle chemotherapy cancer treatment dosing-cycles. The Primary and Secondary Endpoints will be analyzed after the last patient last visit (LPLV) of Stage I. After completing the Stage I double-blind, placebo-controlled primary treatment phase, the subjects will have the option to remain on their assigned treatment arm and reconsented to enter into the Stage II extension phase. Reconsent will be required to enter into Stage II. For subjects who do not reconsent, visit 5 will be the last study visit.
The Johns Hopkins Proton Therapy center is establishing a registry to capture the full 3D radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The goal is to have all patients treated at the proton center to be included in the registry to enable future comparisons of treatment outcomes to assist in understanding which patients can benefit from the use of protons.
Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis. There is increased risk for cardiovascular disease and higher propensity for cardiovascular related mortality among Black and non-Hispanic White patients. Recently, advanced cardiac imaging has become a vital tool in diagnosis and risk stratification of cardiovascular disease. Very limited data is available on the prevalence and characteristics of different cardiovascular diseases in Hispanic and African American minority groups, therefore, studying different racial and ethnic minority groups in the Bronx population is an exceptionally valuable source to determine the prevalence of cardiomyopathies among minority groups along with study survival in this population. This study aims to determine the etiology of cardiovascular disease in a diverse patient population by utilizing various cardiovascular imaging modalities, with a focus on cardiac magnetic resonance (CMR) imaging and to develop risk stratification models by applying advanced cardiovascular imaging markers.
About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.
This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.
Consenting subjects will receive a semi-permanent tattoo in place of the standard of care permanent tattoo for radiation marking at the time of the radiation planning scan. Subjects will be monitored to ensure alignment is the same with the semi-permanent tattoo as the current standard of care. Subjects will be monitored to ensure there are no skin reactions or other side effects. Subjects will be followed for 15 months and will send pictures to the treatment team to ensure that the tattoo fades away within 12 months as expected.
Smoking cessation has been shown to improve the effectiveness and reduce the morbidity of tobacco-related cancer treatments. We will identify effective smoking cessation strategies for patients who are receiving treatment for tobacco-related cancer. In this trial, patients' preferences in smoking cessation therapy will be the principal determinant by providers in developing a three component regimen of pharmaceutical therapy, counseling, and nicotine replacement therapy. This study will identify this cohort's preferences for smoking cessation strategies. We will then examine the impact of utilizing patient preferences upon cessation efficacy by directly comparing cessation success in this study with our recently completed study of the same population using the same tobacco treatments which were randomly assigned.
The purpose of this study is to facilitate the recognition and early management of Immune Related Adverse Events (irAEs) experienced by cancer patients taking immunotherapy. This is done through the development of a web-based platform in which patients receive valuable education about irAEs, patients' irAEs are routinely monitored, patient reported irAEs are embedded into patient clinical care, and patient-provider communication and prompt management of irAEs is facilitated. The intervention component includes access to the web-based platform, routine monitoring of irAEs every week for twelve weeks and then bi-weekly for an additional eight weeks, and messages to healthcare providers and patients if a reported irAE is deemed severe enough that it warrants provider attention. Participants are randomized into either an intervention group (described above) or a control group, in which their irAEs are monitored once after a twelve week interval and again after an additional eight weeks. Additionally, both intervention and control participants complete three assessments: baseline (at the beginning of the research study), 12-week follow-up, and 20-week follow-up.
The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, TKI adherence and health related quality of life (HRQoL), in patients taking TKIs for cancer management. The intervention components include psychosocial management strategies, cancer medication knowledge and embedded physician reports. The intervention will be delivered via an online application over an 8-week period. Participants in the intervention will complete bi-weekly side effect questionnaires as part of their study involvement, which may trigger an alert to their prescribing physician if they reach a certain threshold. Participants in the control will not complete these questionnaires. Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline) and a 6-month follow-up.
This is an observational study that includes patients with breast cancer or non-small cell lung cancer who will be treated with immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.
Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised. It is a side effect of cancer therapy which can occur as commonly as in 1 in 5 patients. When this occurs, heart failure medications are started to protect the heart from progressing to heart failure. With early detection and treatment, heart function recovers to normal in \>80% of patients. Unfortunately, heart failure medications are associated with an undesirable long-term pill burden, financial costs, and side-effects (e.g., dizziness and fatigue). As a result, cancer survivors frequently ask if they can safely stop their heart failure medications once their heart function has returned to normal. Currently there is no scientific evidence in this area of Cardio-Oncology. To address this knowledge gap, the investigators have designed a randomized control trial to assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. The investigators will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. The investigators will randomize patients with no other reasons to continue heart failure medications (e.g., kidney disease) to continuing or stopping their heart medications safely. All patients will undergo a cardiac MRI at baseline, 1 and 5 years with safety assessments at 6-8 weeks, 6 and 9 months and 3 and 5 years. The investigators will determine if stopping medications is non-inferior to continuing medications by counting the numbers of patients who develop heart dysfunction by 1 year in each group.
This research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin is from a family of medications that are commonly called "statins"
This study will evaluate serum vitamin D (25(OH)D) and serum leptin levels at the time of diagnosis of ovarian, primary peritoneal, and/or fallopian tube cancer as well as vitamin D receptor mutation status (FokI SNP genotype). The study will evaluate the impact of vitamin D repletion on serum vitamin D levels, serum leptin levels, and treatment-related morbidity in these patients.
Objectives: The objective of this study is to develop a valid and reliable measure of the symptom burden experienced by patients with cancer experiencing disease-related skin problems and to delineate this burden over time. The Primary Aim is to develop and validate an M.D. Anderson Symptom Inventory (MDASI) module (the MDASI-Derm), compliant with FDA standards for patient-reported outcomes (PROs), to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with cancer-related skin problems. We hypothesize that the MDASI-Derm will be valid and reliable for measuring the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with cancer-related skin problems. The Secondary Aims are: 1. to develop a detailed description of the severity and interference with daily activities of symptoms experienced by patients with cancer-related skin problems; 2. to assess the impact of symptom severity on standard function and quality of life (QOL) measures including both quantitative (Eastern Cooperative Oncology Group \[ECOG\] Performance Status, single-item QOL, and Skindex-16 scales) and qualitative measures (patient interviews); 3. to evaluate the MDASI-Derm as an estimate of functional status and QOL in patients with cancer-related skin problems; 4. to identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points in patients with cancer-related skin problems; 5. to define the qualitative symptom experience of patients with cancer-related skin problems; 6. to explore the feasibility of the Interactive Voice Response (IVR) system in measuring symptom severity and interference with daily activities over time in patients with cancer-related skin problems.
The researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). This type of joint pain is called AI-associated arthralgia, or AIA, and it is common in people taking AIs. AIA and its associated symptoms can make some people decide to stop taking their medication. The study will look at the effects of two different types of group therapy on participants' cancer-related symptoms (such as pain, fatigue, and anxiety), their ability to continue taking AIs on a regular schedule, and their quality of life. We will measure participants' quality of life by having them fill out questionnaires. Both groups will have 2-hour group therapy sessions once a week, over the course of 8 weeks. During the sessions, you will be in a group of 6-10 participants, who may be a mixture of patients from both MSK and University of California San Diego (UCSD).
This randomized phase II clinical trial studies probiotic supplementation in preventing treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may help prevent diarrhea caused by treatment with chemotherapy.
The goal of this clinical research study is to learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy.