Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies

Study Overview
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Brief Summary
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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 best interests.

Official Title
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Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies

Conditions
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Hypomagnesemia

Intervention / Treatment
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* Other: Magnesium Oxide
* Other: Magnesium Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Palliative-intent treatment with Cisplatin, Carboplatin, Panitumumab or Cetuximab and expected to receive ≥ 2 months of further therapy. Potassium level within normal limits Developed grade ≥1 hMg (Mg < lower limit of normal) ECOG less than or equal to 2 ≥19 years of age Able to swallow tablets/capsules Able to provide verbal consent Exclusion Criteria: baseline creatinine >1.5x upper limit of normal ULN Current use of oral or IV magnesium supplementation (patients who receive 1 gram of magnesium with their standard Cisplatin/Carboplatin chemotherapy regimens are eligible).

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Magnesium oxide<br>Participants will be given standard dose levels of Magnesium oxide according to the level of magnesium in blood. | Other: Magnesium Oxide<br>* Magnesium Oxide<br>|
| Active Comparator: Drug Magnesium citrate<br>Participants will be given standard dose levels of Magnesium citrate according to the level of magnesium in blood. | Other: Magnesium Citrate<br>* Magnesium Citrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who are eligible and agree to participate in RCT. |  | one year | 
| Percentage of medical oncologists who agree to participate in the study at study commencement and approach patients for the study. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnesium levels | Compare the differences in levels of magnesium between the two regimens | One year | 
| Cardiac risk | Determine whether systemic therapy-induced hypomagnesemia poses a serious risk of cardiac arrhythmias as measured by changes in average QTc intervals with changes in magnesium levels. | one year | 
| Cost factors | Determine cost differences between two magnesium replacement strategies. | one year | 
| Rates of treatment delays |  | one year | 
| Rates of hospital admissions. |  | One year |