Research Projects

To be able to research side effects, you need to know which side effects affect the quality of life and treatment (dis-)continuation the most, so you can focus on those first. Ideally, side effect exploration studies should already be performed during phase I and II research, when the first patients are consuming a drug for the very first time.

Al projects of the Impaqtt Foundation are generated in close collaboration with world-renowned scientific and clinical experts in the therapeutic area of side effects. As up till now the number of controlled studies from which evidence-based advice for these mucocutaneous side effects can be formulated is very limited, we established two clinical studies. Currently, the following research projects are ongoing:

The central question of this dissertation was whether available methods and instruments can serve as a basis for the realization of an integrated patient-driven approach to targeted therapy-associated side effects.

The conclusion of Dr. Boers-Doets's thesis was that targeted therapy-associated side effects should be approached in an integrated, interdisciplinary team model of care and in a systematic fashion. The co-care model proposed in her thesis offers a framework for this approach in which the three findings in her thesis can be embedded:

  • The development of a combined three-part patient-reported assessment and grading instrument that maps the symptoms and signs of a side effect and their impact on health-related quality of life.
  • The generation of evidence-based targeted therapy-associated side effect treatment guidelines.
  • Establishing training programs for healthcare providers especially for those involved in clinical trials and those who work on a daily basis with patients on targeted therapies is indicated.

Her thesis was intended to provide an early view into a patient-driven approach to targeted anticancer therapy-associated side effects conceptual co-care model which is expected to have a future impact on improving the patients’ quality of life, improving the outcome of the targeted anticancer therapy, and lower the costs of side effects treatment.

Initiation of the most appropriate side effect treatment is more likely to occur if the 6 steps of the TARGET strategy are taken

Purpose: A substantial number of patients on targeted anticancer therapy cannot complete their treatment as planned, due to severe or persistent side effects associated with these agents, which may affect clinical outcomes. An effective approach to side effects is needed in order to help patients complete treatment as planned.

Objectives: The aim of this work was to identify a more detailed description of the side effects so that available treatment options can be provided leading to a decrease in dose modifications and continuing compliance with cancer care.

Methods: In part I, the medical records and clinical trial protocols of oncology patients on targeted therapy were searched. We explored terms used to describe side effects and documented missing information in a detailed side effect diagnosis. In part II, the core items identified in part I were applied on patients with side effects of targeted therapy and recorded if patients were able to complete treatment as planned.

Results: In part I we identified six core side effect items, which were organized in six TARGET-steps: term, assess, report, grade, educate, and treat. 

In part II the side effects of 262 patients were approached according to the identified six TARGET-steps. At initiation, a total of 1.516 side effects was reported. 

The most frequent side effects patients and questioners’ requested advice for in the study were dry skin, burning sensation, pruritis, and dry oral cavity; 244 (16.1%), 201 (13.3%), 193 (12.7%) and 102 (6.7%) respectively. 98% of the side effects were decreased from moderate or severe to none or mild within 48 hours of side effect treatment. No cancer treatment adjustments were performed.

Conclusion: Initiation of the most appropriate AE treatment is more likely to occur if the 6 steps of the TARGET strategy are taken.

This clinical trial (NCT01136005) is a phase III randomized double-blind trial of Bepanthen® cream versus Cetomacrogol cream in the prevention of papulopustular eruption in patients receiving EGFRI (BeCet) in collaboration with the Impaqtt Foundation (Responsible Party), Waterland Hospital, Leiden University Medical Center, and Bayer.
NaCl-0.9% versus caphosol


This clinical trial (NCT01265810) is a phase III randomized double-blind cross-over trial of supersaturated calcium-phosphate rinse (Caphosol®) versus NaCl 0.9% in the relief of oral mucositis in patients receiving targeted therapy (COMTT) in collaboration with the Impaqtt Foundation (Responsible Party), Waterland Hospital, Leiden University Medical Center, and EUSA Pharma.

To be able to disseminate the gained knowledge

and to set up new trials,

independent funding is needed