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NCT ID: NCT05078671 Recruiting - Cancer Clinical Trials

Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness

PROACTIVE
Start date: December 15, 2021
Phase: Phase 4
Study type: Interventional

Olaparib is a poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, originally used for the maintenance treatment of women with platinum-sensitive relapsed breast cancer gene (BRCA)-mutated high grade serious epithelial ovarian, fallopian tube, or peritoneal cancer, who are in response to platinum-based chemotherapy. Over the last two years, several therapeutic indications have been added to the drug label, such as first-line platinum-sensitive BRCA-mutated high grade serious epithelial ovarian, fallopian tube, or peritoneal cancer, germline BRCA1/2-mutated, human epidermal growth factor 2 (HER2-)negative, locally advanced or metastatic breast cancer and BRCA1/2-mutated metastatic castration-resistant prostate cancer, who have progressed following prior therapy. Since olaparib is very expensive, this increase of treatment population will have a significant impact on health care expenditures. To keep healthcare affordable and accessible for all patients, innovative strategies are warranted to reduce the dose of expensive drugs, without reduction of efficacy. For olaparib, pharmacokinetic (PK) boosting can be applied. PK boosting is the lay term for administering a non-therapeutic active strong inhibitor of a metabolic enzyme, for example the cytochrome p450 enzyme 3A (CYP3A), together with a therapeutic drug that is metabolized by the same enzyme. Boosting thus increases the concentration of the therapeutic drug and allows lower doses to be administered to patients. Hence, coadministration of a reduced dose of olaparib with cobicistat, a non-therapeutic, strong inhibitor of the CYP3A can lead to equivalent exposure to olaparib. Furthermore, inhibition of CYP3A could lead to less PK variability since metabolic capacity is a prominent cause for (intra- and inter-individual) variability in systemic exposure. Predictable olaparib exposure will reduce the number of patients who are unintentionally under- or overtreated. Lastly, tumor tissue itself may express CYP3A as a detoxification or resistance mechanism. Theoretically, PK boosting may also overcome CYP3A-mediated drug resistance. The purpose of this study is to establish the efficacy, safety and feasibility of co-administering olaparib with the PK booster cobicistat with the aim to implement boosting approach for olaparib in routine practice. The study is subdivided in two parts. In part A of the study the equivalent exposure of boosted low dose olaparib is determined compared to the normal dose. In part B of the study, non-inferiority of the boosted olaparib regimen will be confirmed.

NCT ID: NCT05076916 Completed - Cancer Clinical Trials

The Effectiveness of the Web-based Education Programme Among Cancer Patients

Start date: May 2014
Phase: N/A
Study type: Interventional

This study aims to develop a web-based education program among cancer patients undergoing treatment of systemic chemotherapy and to evaluate the effect of the program on symptom control, quality of life, self-efficacy, and depression. Evaluating the effect of the web-based education programme among cancer patients will be useful in planning appropriate remote nursing interventions to increase the symptom control and quality of life of patients. A web-based education program was prepared in line with patient needs, evidence-based guidelines, and expert opinions and tested with 10 cancer patients. A single-blind, randomised controlled study design was applied. Pre-tests were applied to 60 cancer patients undergoing systemic chemotherapy, and the patients (intervention:30, control: 30) were randomized. The intervention group used the web-based education program for three months, and they were allowed to communicate with the researchers 24/7 via the website. The effectiveness of the web-based education program at baseline and after 12 weeks evaluated.

NCT ID: NCT05076500 Recruiting - Cancer Clinical Trials

Investigating the Tumour Immune Response of Radiotherapy

TIMM-RAD
Start date: July 14, 2021
Phase:
Study type: Observational

This study aims to investigate immune changes which occur before and following standard radiotherapy in a range of tumour types. We will collect tissue and blood samples before and after radiation treatment from participants across six cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma/ basal cell carcinoma.

NCT ID: NCT05075538 Terminated - Cancer Clinical Trials

COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2

I-SPARC
Start date: December 1, 2021
Phase: Phase 4
Study type: Interventional

This trial aims to measure the humoral and adaptive immune response in patients with cancer diagnosis undergoing mRNA vaccination against SARS-CoV-2 and assess its efficacy in preventing COVID-19.

NCT ID: NCT05070897 Completed - Cancer Clinical Trials

Health Literacy and Digital Health in Cancer Patients.

LICAPA
Start date: September 27, 2021
Phase:
Study type: Observational

This is a multicentric, prospective, observational, transversal study, aiming to evaluate the health literacy of cancer patients using the approved French version of the Functional, Communicative and Critical Health Literacy (FCCHL) scale in 2 populations: - Population A: patients age 65 and over treated in an oncology or oncogeriatric outpatient clinic, or seen in an oncology or oncogeriatric consultation. - Population B: young patients age 18 to 64 treated in an oncology or outpatient clinic, or seen in an oncology consultation. The following questionnaires: - Approved French version of the FCCHL scale - Questionnaire on the use of digital tools adapted from the questionnaire on digital tools, will be completed once only. It will be completed by the participant during the oncology or oncogeriatric consultation or outpatient clinic appointment, in self-questionnaire mode or face to face, assisted if necessary by a family member or member of the medical team.

NCT ID: NCT05069662 Completed - Cancer Clinical Trials

Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients

ONCORAL-Covid
Start date: October 5, 2021
Phase:
Study type: Observational

The COVID-19 pandemic has profoundly changed the organisation of care. Teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus. Within the framework of the Oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the Hospices Civils de Lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital. This study focuses on a telephone survey to describe the impact of the COVID-19 pandemic health crisis on the drug exposure of cancer patients followed in the Oncoral program, their treatment management, their perception of teleconsultation and their IT resources for remote monitoring.

NCT ID: NCT05069519 Completed - Cancer Clinical Trials

Implementing Personalized Exercise Prescriptions Through Mobile Health in the Elderly Cancer Survivors

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

Cancer remains a vital public health concern in the U.S. Research evidence has shown that physical activity provides many physical and mental health benefits after cancer diagnosis and plays an important role in reducing all-cause, cancer-related death and cancer events in the elderly cancer survivors (CS). Adopting a physically active lifestyle may decrease cancer risks, improve cancer prognosis and quality of life. However, most CS did not achieve recommended 150 min/week of moderate-to- vigorous physical activity (PA [MVPA]). This issue is particularly pronounced for CS in low-income areas who tend to have considerably less access to PA-conducive environments compared to urban peers. To this accord, it is imperative to promote PA in elderly CS to offer appropriate supportive care. Thus, implementing innovative PA interventions with the goal of improving their self-regulatory health behaviors in CS is paramount.

NCT ID: NCT05068869 Active, not recruiting - Cancer Clinical Trials

Digital Outpatient Services

Start date: September 12, 2021
Phase: N/A
Study type: Interventional

More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. Further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. By developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase. The aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. Furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. In addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes. The current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. In total, eligible participants will be recruited from one of four centers.

NCT ID: NCT05062707 Recruiting - Breast Cancer Clinical Trials

Early Ageing During Therapy in AYA Cancer Patients

Start date: February 10, 2022
Phase:
Study type: Observational

Longitudinal cohort study; measurements before start of systemic therapy and one year later.

NCT ID: NCT05062525 Completed - Cancer Clinical Trials

Immune Response to COVID-19 Vaccine in Immunotherapy (IO) and Non-IO Treated Cancer Patients

VIVACIOUS
Start date: September 28, 2021
Phase:
Study type: Observational

Evaluation of antibody response against SARS-CoV-2 vaccination in patients treated with IO-treatment, in comparison with antibody titers in patients treated with non-IO treatment.