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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Magnesium oxide | Active Comparator | Participants will be given standard dose levels of Magnesium oxide according to the level of magnesium in blood. |
|
| Drug Magnesium citrate | Active Comparator | Participants will be given standard dose levels of Magnesium citrate according to the level of magnesium in blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Oxide | Other | Magnesium Oxide |
| |
| Magnesium Citrate |
| 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 |
| 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. |
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Inclusion Criteria:
• Palliative-intent treatment with Cisplatin, Carboplatin, Panitumumab or Cetuximab and expected to receive ≥ 2 months of further therapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Vickers, Dr. | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H8L6 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 29, 2022 | |
| Reset | Aug 14, 2023 |
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| Other |
Magnesium Citrate |
|
| 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 29, 2022 | Aug 14, 2023 |
| ID | Term |
|---|---|
| D008277 | Magnesium Oxide |
| C110422 | magnesium citrate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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