A Spanish SME specialized in design and management of Strategic Clinical Trials is writing a proposal for the call H2020-SC1-BHC-23-2018. The project aims to evaluate the efficacy of one promising natural compound as a dietary supplement in the improvement of side effects related with cancer treatment. They are looking for partners with expertise in biomarkers analysis and pharmaeconomics, dietary supplements manufacturers and health-app developers. They are also looking for a coordinator.
Cancer patients that have been treated with chemotherapy experience complex interactions of associated symptoms related with late and long-term toxicities and side-effects. Many of these symptoms risk chronification and imply an enormous burden to European public health systems. Furthermore, those symptoms are also related with a swift deterioration of the patients’ capacity to successfully return to their previous social and professional lifestyles, with the significant impact this entails on society as a whole.
Many of these late symptoms already appear during acute treatment phase, suggesting that the initial control of these symptoms during treatment might result in an improvement of the long-term patient state. A great number of preclinical studies have shown that the active principles present in natural products are able to regulate factors such as oxidative stress, inflammation and immunomodulation. Nevertheless, strong clinical evidence regarding the actual efficacy of dietary supplements in treating cancer treatment-induced late symptoms is still lacking. The fact that nearly half of patients diagnosed with cancer report they take dietary supplements as a consequence of their diagnosis further highlights the urgent need to generate strong scientific evidence about the potential of these products. Lack of strong clinical evidence regarding these products (not only about their efficacy, but also about their possible interactions with current conventional drugs) greatly complicates physicians’ role when advising patients about their use, which is a growing demand in modern cancer medical practice.
In this project the company intends to carry through two strategically designed phase II clinical trials to evaluate the efficacy of a promising natural compound as a dietary supplement in the improvement of both acute and long-term side effects related with cancer treatment in patients and survivors. They will focus on symptoms with the potential to become chronic and which entail a huge impact both in Public Health Systems and in social productivity.
In short, they plan to study the efficacy of the selected supplement to ameliorate the state of cancer-treated subjects, and also the potential interactions and positive synergies arising between the selected supplements and the conventional therapies received by the patients. Subjects will be monitored in order to check the effect of dietary supplementation during the acute treatment stage and in their long-term symptoms. One study will recruit newly diagnosed patients starting anticancer therapy, to see if by controlling acute symptoms during the treatment phase it is possible to decrease the prevalence and severity of long term side effects once patients are finished with their treatments and acquire survivor status. The second study will recruit survivors exhibiting long-term side effects from previous cancer treatment, to check whether this strategy can also be used when the patients are already symptomatic.
• Generation of strong clinical evidence on the feasibility of the use of dietary supplements derived from natural products to prevent and manage long-term symptoms of cancer treatment
• Reduced symptom burden and suffering or improved well-being of patients in need of survivorship care and their formal and informal caregivers
• Improved clinical guidelines and policy recommendations with respect to survivorship care of patients afflicted by late and long term side-effects
• Improved quality, effectiveness and cost-effectiveness of survivorship care services as well as access to care
• Reduced economic and wider societal burden arising from increased numbers
Call: H2020 - SC1-BHC-23-2018: Novel patient-centered approaches for survivorship, palliation and/or end-of-life care.
Deadline for EOIs: 02 April 2018
Deadline for Call: 18 April 2018
- Specific area of activity of the partner: • Institution with expertise in the management/coordination of European H2020 Projects: Financial Administration of the project, Contractual and IPR management, meeting organization, etc.
• Institution with expertise in biomarker analysis in biological samples: Exploratory study of biomarkers able to predict response and resistance to the compound.
• Company with expertise in pharmacoeconomics: Evaluate the potential impact of the proposed approach considering the obtained results.
• Company who produces/markets dietary supplements from natural products: Generate the supplement to be used in the Study. Protect and market related products.
• Company with expertise in the development of health apps: Develop a method to remotely register and monitor patients’ physical, emotional, mental, social, and environmental state, including their use of complementary and alternative medicine (an app questionnaire of Quality of Life/concomitant integrative approaches).
• Cancer Patients Association: Review Quality of Life questionnaires. Review health app. Participate in results dissemination.
Proposal under development
Coordinator required: No
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