Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies
Hypomagnesemia (hMg) is a common side effect of important anti-cancer therapies such as
epidermal growth factor receptor inhibitors (EGFRIs) and platinum-containing anti-cancer
drugs. EGFRIs, including cetuximab (cmab) and panitumumab (pmab), have been estimated to
cause hMg in over 18% and 27% of patients respectively1, while 90% of patients receiving
cisplatin will develop hMg if left untreated. The development of severe hMg may result in
increased symptoms such as fatigue, neuromuscular changes, mental status changes and cardiac
arrhythmias which could result in treatment delays and may compromise treatment efficacy.
Despite the common occurrence of this toxicity, little is known regarding the optimal
magnesium management strategy. As physicians do not know what the "best" treatment for
patients is, genuine uncertainty ("clinical equipoise") exists. Physicians will choose
between different "standards" of magnesium replacement in their personal practice, using
idiosyncratic decision making processes, without the physician or the patient knowing the
optimal option. This is not good for patients, physicians and society as a whole.
Determining the optimal treatment remains an important medical issue for patients,
physicians and society. This study will use a novel method to allow comparisons of
established standard of care prophylactic treatment using the "integrated consent model" as
part of a pragmatic clinical trial7. By integrating medical and clinical practices,
physicians will be able to inform their patients about the randomized control trial, akin to
a typical conversation between the physician and patient, without written informed consent.
This clinical interaction would then be documented, as ordinarily done in practice. Medical
and clinical practice will be intertwined with the patients' welfare at the forefront of our
View this trial on ClinicalTrials.gov
Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.
These resources are provided in partnership with the
Canadian Cancer Society