View clinical trials related to Cancer.
Filter by:Clinical Data Validation of a Novel Continuous Vital Sign Monitoring System in Cancer Patients Background The Cortrium C3 device is a novel, inexpensive, chest-worn unit designed for measuring vital sign parameters. The unit is capable of logging and wireless transmitting data describing pulse, respiratory rate, body surface temperature, ambient temperature and accelerometer data (1,2). The C3 device is developed as a diagnostic tool in the medical practice to meet the demand for a modern reliable and open medical grad vital sign monitoring system. The device is based on state-of-the-art technologies and is produced using high quality off-the-shelf components. Although, new technologies may be of high value to the health care system, studies show that the quality of technologies vary and more empiric data is needed to either support or reject the advantages of using intelligent health technologies at home (3-5). Besides measuring the actual quality of C3, it is therefore also important to evaluate how patients experience quality in relation to C3 in addition to an evaluation of perspectives from the health professionals. Objective The objective of the study is to validate measurements of pulse, frequency of respiration, and temperature obtained with the C3 device by comparison with routinely used hospital equipment. Further, the objective is to gain knowledge about how patients experience to be monitored with C3 and how hospital staff experience working with C3. Design and participants The study is carried out on cancer patients at the Department of Oncology, Naestved Hospital, Region Zealand, Denmark (DONZ). Collaborating partners are Cortrium, University College Zealand and Sundhedsinnovation Zealand. The study consists of a quantitative and a qualitative part. The quantitative study is a cross-sectional study of paired measures of vital sign parameters (pulse, respiratory rate and temperature) measured by the C3 device and standard hospital equipment used at DONZ. The qualitative study is planned as observational studies and semi-structured interviews with patients, who have been monitored with C3 and health professionals who have been involved in treatment or care of monitored patients. Recruitment of participants will take place amongst newly hospitalized patients at DONZ. It is planned to include approximately 40 patients in February and March 2016. Side effects, risks and inconveniences No major side effects are related to wearing and being monitored by the C3 device. The device has been tested on healthy volunteers and reports of inconveniences are mostly related to the adhesive ECG-electrodes that can irritate the skin. However, a wide array of electrodes are commercially available to fit the individual needs. Some might find wearing the device stigmatizing and/or inconvenient. In addition, the C3 device is marked CE class I. Hence, requirements for prevention of adverse effects are met. As an example, this includes two fuses between the battery and the electrodes, minimizing the risk of current for the battery entering the body even in the event of device failure. The device has not yet been approved for commercialization. Ethics and anonymization All data collected in the study is done according to the guidelines of Good Clinical Practice (GCP) for medical device studies (6). All data is anonymized, and is protected according to national law: "Lov om behandling af personoplysninger". The project has been reported to "Datatilsynet" [the Data Protection Agency]. Test subjects are secured access to further information about the study through their assigned nurse or email and telephone. Approvals The study has been approved by the Danish Ethical Comity: SJ-460, and The Danish Medicines Agency: journal number 2015120113.
Background: There is some evidence demonstrating the effect of psychological interventions in improvements in health biological parameters. To best of our knowledge, no study had addressed the impact of any psychological intervention on extracellular vesicles. In addition, Mindfulness-Based Cognitive Therapy (MBCT) and Emotion Focused Therapy for Cancer Recovery (EFT-CR) in the group have never been explored regarding extracellular vesicles and the effectiveness of these was not compared yet. Objectives: 1. To explore and compare the effect of MBCT and EFT-CR on biological parameters and psychological variables in distressed people who have had breast, prostate and colorectal cancer; 2. In addition, we will explore the acceptability through recruitment and retention rates of MBCT and EFT-CR in group and evaluate whether these interventions are appropriate for a larger clinical trial. Methods: The design of this study is a parallel randomized controlled trial. Participants will be randomized into MBCT, EFT-CR or usual care. Outcome measures will be assessed before, at the end of the intervention (8 weeks) and follow-ups (24 and 52 weeks from the baseline moment). Hypotheses: The researchers expected that both interventions will have an effect on extracellular vesicles and other study biomarkers as well as improvements in psychological outcomes, compared to treatment as usual (TAU) group. Regarding the comparative effectiveness, we did not have evidence to hypothesize which one of the interventions will be superior in both biological (extracellular vesicles) and psychological outcomes. Contribution for practice: The results of this preliminary study would permit to know if there are benefits of these psychological interventions on changes in extracellular vesicles and on psychological outcomes related to health. In addition, this study will permit to determine the acceptability of conducting a larger randomized controlled trial.
PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care. It is at the first stage aimed to high-risk patients undergoing major surgery. Better condition before the surgery is proved to reduce the perioperative complications and to improve patients' health-related quality of life while cutting the associated costs. The concept integrates short-term (average 4 weeks) preoperative interventions including endurance training, promotion of physical activity and nutritional and psychological support. Interventions are planned both at community and at hospital reducing unnecessary interactions between patients and tertiary care. PAPRIKA tackles three major drivers: i) human perspective ii) organizational challenges and iii) technical aspects. The project is based on previous experience on prehabilitation and the already refined service using design thinking methodologies. It will be also based on the proven reduction of associated costs for the healthcare system.
Opioid-Induced Constipation (OIC) is often associated with a compromised quality of life of patients in palliative care (PC) setting. Among the Peripherally-Acting Mu-Opioid Receptor Antagonists, Naloxegol is the most effective to treat OIC and to improve OIC-related aspects of quality of life in patients with non-cancer pain. This observational study aims to assess the impact of a 4-weeks Naloxegol therapy on the quality of life in advanced cancer patients with OIC assisted by a home PC program. The study is enrolling cancer patients with OIC (defined according to Rome IV criteria) not relieved by first-line laxatives, starting the therapy with 25 mg/day of Naloxegol. The main parameters evaluated at the beginning of the therapy (T0) and after 28 days (T28) are: Patient Assessment of Constipation Quality-of-Life (PAC-QoL, 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, satisfaction), evaluation of objective (number of weekly evacuations) and subjective constipation (Bowel Function Index, BFI, normal score<30), pain assessment by NRS.
Caregivers of patients with advanced cancer will be entered. Participants will be randomized to one of two study arms: Arm 1: Progressive muscle relaxation; Arm 2: Attention matched control. Hypothesis: Progressive muscle relaxation will decrease caregiving burden and severity of fatigue and improve quality of life.
This is a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study is divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).
A substance called integrin alpha v beta six (αvβ6) is found to be increased in some cancer cells and can play an important role in the development and spread of cancer. If the levels of integrin αvβ6 in cancer cells can be measured by carrying out PET scans, we might be able to identify and potentially treat tumours. FBA-A20FMDV2 is a substance that binds or sticks to integrin αvβ6. It may therefore be possible to find and measure the amount of integrin αvβ6 in tumours. To do this a small amount of radioactivity will be attached to FBA-A20FMDV2 and carry out a scan called a Positron Emission Tomography (PET) scan. FBA-A20FMDV2 attached to radioactivity is known as [18F]FBA-A20FMDV2 or a radiotracer, as a very small amount of tracer dose is given to humans. So far such scans have been carried out in healthy volunteers and in patients with a lung condition called idiopathic pulmonary fibrosis (IPF). This was to assess the safety of the radiotracer and how it is taken up in the body. However, such scans have not been performed in cancer patients. This study will help specifically investigate αvβ6 in patients with cancer and find out how [18F]FBA-A20FMDV2 is taken up in tumours. With this information, the ideal imaging method for patients with cancer can be developed.
An observational study to investigate cachexia in participants with non-haematological cancer.
This protocol is a prospective, observational study of participants receiving immunotherapy (checkpoint inhibitors, CPI) for cancer therapy, testing the hypothesis that patients with immune related cutaneous adverse events (ircAEs) have unique immunologic endotypes associated with polarized immune responses.
This project aims to explore, in depth, the burden of hearing loss and tinnitus on cancer survivors. Using semi-structured interviews, audiograms and a variety of validated questionnaires, the specific impact ototoxicity has on quality of life will be investigated. From this, we can identify the specific needs of patients experiencing hearing loss and tinnitus following chemotherapy and develop a tailored and personalised support system.