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NCT ID: NCT05490641 Recruiting - Cancer Clinical Trials

Know and Own Your Movement-related Metrics Via Wearable Devices

Project KNOWN
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study aims to promote daily physical activity in cancer survivors who are at high risk for type 2 diabetes (T2D) by using a personalized biological-based feedback strategy. T2D is one of the most common co-occurring conditions in cancer survivors and can worsen cancer-related health outcomes, especially in those who are insufficiently active. The investigators hypothesize that seeing the immediate impacts of exercise on their biological status will motivate cancer survivors to exercise. The investigators will use real-time data from continuous glucose monitor to demonstrate the acute impact of physical activity and measure daily activity levels using wearable trackers. As wearable sensor technology is constantly advancing, this study is the first step to exploring how researchers can use wearable sensors to help people make a direct connection between their daily behaviors and health outcomes.

NCT ID: NCT05490524 Recruiting - Cancer Clinical Trials

Smart Living Homes: a Pilot RCT of GATEKEEPER System in Cyprus With Patients With Cancer and Dementia

GATEKEEPER
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

The main objective of the Project is to create a GATEKEEPER, that connects healthcare providers, businesses, entrepreneurs, elderly citizens and the communities they live in, in order to originate an open, trust-based arena for matching ideas, technologies, user needs and processes, aimed at ensuring healthier independent lives for the ageing populations. By 2022, GATEKEEPER will be embodied in an open source, European, standard-based, interoperable and secure framework available to all developers, for creating combined digital solutions for personalised early detection and interventions that (i) harness the next generation of healthcare and wellness innovations; (ii) cover the whole care continuum for elderly citizens, including primary, secondary and tertiary prevention, chronic diseases and co-morbidities; (iii) straightforwardly fit "by design" with European regulations, on data protection, consumer protection and patient protection (iv) are subjected to trustable certification processes; (iv) support value generation through the deployment of advanced business models based on the VBHC paradigm. GATEKEEPER will demonstrate its value by scaling up, during a 42-month work plan, towards the deployment of solutions that will involve ca 40.000 elderly citizens, supply and demand side (authorities, institutions, companies, associations, academies) in 8 regional communities, from 7 EU member states. Recently 3 Asian pilots have been added as a result of the Open Calls. The achievement of the overall objective is supported by the following, among others, specific objective: To execute a series of PILOTS to demonstrate the effect, benefit, value and scalability of the GATEKEEPER solutions around REFERENCE USE CASES COVERING PRIMARY, SECONDARY and TERTIARY PREVENTION, initially deployed in 8 regions of 7 European countries. The Cyprus pilot mainly focuses on the early detection of the condition worsening of cancer and dementia patients by monitoring whether the use of technology can trigger appropriate management, thereby reducing the need for higher acuity care, and even, at times, improving survival by supporting demand-driven solutions through high-quality health mobile systems.

NCT ID: NCT05488184 Completed - Cancer Clinical Trials

Study to Evaluate the Organoleptic Perception of Oral Nutritional Supplements for Oncological Patients

SENSORIAL
Start date: June 26, 2019
Phase: N/A
Study type: Interventional

Nutritional therapy is key to helping cancer patients get the nutrients they need to maintain body weight, strength, tissue and organ integrity, and face likely infections. Some cancer treatments work best when the patient is well nourished and has enough calories and macronutrients from food. According to the latest consensus, the first step in nutritional intervention is nutritional recommendations or dietary advice. These recommendations must be realized if the patient is capable of ingesting at least 75% of the nutritional requirements that correspond to them and, if there is no approach to an upcoming risk therapy. As long as the oral route is not damaged, in dietary advice this should always be the first option. Increasingly, laboratories specialized in nutritional products prepare and improve the composition of supplements. They are complete, specific and perfect to meet the dietary needs of patients who require it. But, to fulfill their function, they have to be ingested by people and for that they have to have good organoleptic characteristics, a very important nuance that is sometimes not taken into account in the manufacture of these products. It is the object of Adventia Pharma, S.L. develop new Oral Nutritional Supplements specific for cancer patients and that meet optimal organoleptic characteristics. For this reason, a pilot study will be carried out that will evaluate different sensory and organoleptic aspects of the prototypes of supplements developed by the company to determine the consumer's reaction to the products developed and subsequently be able to select the one with the greatest acceptance.

NCT ID: NCT05486260 Recruiting - Cancer Clinical Trials

Effect of Dried Miracle Berry on the Olfactory-gustative Perception in Malnourished Cancer Patients

CLINMIR
Start date: June 23, 2022
Phase: N/A
Study type: Interventional

Cancer is one of the main causes of death globally, being in many countries the first cause of mortality. One of the main side effects of chemotherapy and/or radiotherapy treatment in cancer patients is the alteration of taste and smell, internationally known as these anomalies Taste Smell Alterations (TSA). These alterations are the result of an altered cellular structure, the presence of TSA is associated with reduced quality of life and poor nutrition, due to dietary changes made by these patients. Synsepalum dulcidicum (dried miracle berry, DMB) is a plant belonging to the Sapotaceae family, made up of around 800 species grouped into around 40 genera. It is an indigenous species to the forest regions of West Africa. Nuts of this specie have been approved as a novel food in accordance with Regulation (EU) 2015/2238 and at the request of the European Commission through the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens. The characteristic component of DMB is miraculin. Miraculin is a glycoprotein whose consumption causes acidic and sour foods, and to a lesser extent bitter, to be perceived as having a sweet taste. In this sense, it is possible that the consumption of DMB before each meal can improve sensory perception after treatment with chemotherapy or radiotherapy.

NCT ID: NCT05485974 Not yet recruiting - Cancer Clinical Trials

A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation

Start date: August 2022
Phase: Phase 1
Study type: Interventional

A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.

NCT ID: NCT05485792 Not yet recruiting - Cancer Clinical Trials

18F-FAPI and 18F-FDG PET/CT in Patients With Various Types of Cancer

FAPI-VTC
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.

NCT ID: NCT05479851 Not yet recruiting - Cancer Clinical Trials

ORCA: Opportunities to Raise Cancer Awareness After Referral: Survey of Patient Views

ORCA
Start date: September 1, 2022
Phase:
Study type: Observational

The purpose of this study is to investigate what patients think about increasing provision of advice about how to detect cancer early and how to reduce their future cancer risk after they are discharged from a two-week wait referral pathway for suspected cancer. This study will send a postal survey to patients living in the UK who were recently referred onto the suspected cancer pathway and were discharged without a cancer diagnosis (i.e. a negative diagnosis). Patients will be presented with different types of support and patients' views of the burden, benefits, understanding and perceived effectiveness of each one will be measured.

NCT ID: NCT05479682 Not yet recruiting - Cancer Clinical Trials

Investigating the Equivalence of the EORTC QLQ-C30 and the QLQ-F17

Start date: August 1, 2022
Phase:
Study type: Observational [Patient Registry]

The EORTC QLQ-C30, a patient-reported outcome measure (PROM) that is available in 110 different languages, has been used in thousands of clinical cancer trials worldwide. The QLQ-C30 is composed of six functioning scales (including a measure for global quality of life), three symptom scales, and six single items. Researchers and regulatory bodies came up with the idea to construct a shortened EORTC questionnaire that solely consists of functioning scales and to use additional symptom items according to the side effect profile of the specific medication under investigation. This shortened form termed QLQ-F17 includes the Physical Functioning (PF), Role Functioning (RF), Emotional Functioning (EF), Cognitive Functioning (CF), and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. This functioning questionnaire can be amended with symptom-specific items taken from the EORTC item library. This method provides a flexible and economic testing strategy that fits the demands of regulators and users in industry and academia. It is an open question, however, whether the QLQ-F17 is equivalent to the QLQ-C30 in terms of measurement properties. Based on empirical research on response biases and order effects, one might argue that elimination of the symptoms between RF and CF-Dyspnea (DY), Pain (PA), Fatigue (FA), Insomnia (SL), Appetite (AP), Nausea/Vomiting (NV), Constipation (CO), and Diarrhea (DI)-and of the Financial difficulties (FI) item between SF and QL may alter the manner in which subsequent items are completed. Thus, from a methodological point of view, it is essential to confirm the psychometric properties of the QLQ-F17 and to present evidence that scale values derived from the QLQ-F17 are equivalent to those of the QLQ-C30. Only in the case of equivalence may studies using either of the two basic questionnaires be compared directly. The present project is designed to address this research question. This is an international multicenter survey study that will include respondents with cancer from Australia, Finland, France, Germany, Italy, Poland, Romania, Spain, Sweden, and United Kingdom. A randomized cross-over design will be applied, enabling between-patients as well as within-patients comparisons of the QLQ-C30 and the QLQ-F17. One group of respondents will first fill in the QLQ-C30 followed by the QLQ-F17, the other group will start with the QLQ-F17 followed by the QLQ-C30. A sample size of 1.500 cancer patients is sufficient to get precise estimates with narrow confidence intervals regarding item and scale-level agreement. Thresholds and margins to be used for the analyses in this study will be consented by a statistical advisory group. Reliability and psychometric properties can also be precisely estimated with a sample of this size. The present study is based on the hypothesis that the QLQ-F17 and the QLQ-C30 questionnaires are equivalent.

NCT ID: NCT05477784 Recruiting - Cancer Clinical Trials

Enhancing Connections-Palliative Care: A Cancer Parenting Program for Patients With Advanced Cancer and Their Children

EC-PC
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

This is a multi-site Phase 2, 2-group randomized control trial that will test the efficacy of a 5-session, telephone-delivered cancer parenting program for child-rearing patients with non-curable cancer. Aim 1: To assess the efficacy of the intervention on parents' and children's primary outcomes at 3 months using Linear Mixed Models within an intent to treat analysis and per protocol analysis. Aim 2: To test the underlying theoretical model of the intervention using structural equation modeling with confirmatory factor analysis. Aim 3: To examine the impact of the intervention on children's depressed mood, anxiety, and Internalizing and Externalizing problems whose parent dies during participation in the study. Aim 4: To examine the moderating effects of parents' symptom burden and family environment on treatment outcomes. After obtaining signed informed consent, participants will be randomized to the experimental or control group. Assessments will be obtained at baseline and at 3, 6, and 9-months post-baseline using standardized questionnaires. Parents randomized to the experimental group will receive the 5-session EC-PC Program at 2-week intervals delivered by telephone by specially trained patient educators. The control group will be mailed the booklet, "Having a Successful Conversation with Your Child," a guide for child-rearing parents with advanced cancer, and will receive a fully scripted phone call from a trained patient educator. Efficacy will be evaluated at 3-months post-baseline on 5 primary outcomes: child's depressed mood and anxiety; parents' depressed mood; parents' anxiety the parent's confidence in being able to talk with their child about the child's cancer-related concerns; and the parents' skills in helping their child cope and manage the toll of the parents' cancer. The stability of changes will be described and evaluated at 6- and 9-months.

NCT ID: NCT05474846 Not yet recruiting - Depression Clinical Trials

Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer

Start date: December 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this study, BLT, Methylphenidate and Melatonin will be compared to their placebos.