OTT 15-03: Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Drug Magnesium oxide Participants will be given standard dose levels of Magnesium oxide according to the level of magnesium in blood. |
Other: Magnesium Oxide
Magnesium Oxide
|
| Active Comparator: Drug Magnesium citrate Participants will be given standard dose levels of Magnesium citrate according to the level of magnesium in blood. |
Other: Magnesium Citrate
Magnesium Citrate
|
Outcome Measures
Primary Outcome Measures
- 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
- Magnesium levels [One year]
Compare the differences in levels of magnesium between the two regimens
- Cardiac risk [one year]
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.
- Cost factors [one year]
Determine cost differences between two magnesium replacement strategies.
- Rates of treatment delays [one year]
- Rates of hospital admissions. [One year]
Eligibility Criteria
Criteria
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
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Developed grade ≥1 hMg (Mg < lower limit of normal)
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ECOG less than or equal to 2
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≥19 years of age
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Able to swallow tablets/capsules
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Able to provide verbal consent
Exclusion Criteria:
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baseline creatinine >1.5x upper limit of normal ULN
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Current use of oral or IV magnesium supplementation (patients who receive 1 gram of magnesium with their standard Cisplatin/Carboplatin chemotherapy regimens are eligible).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Ottawa Hospital Cancer Centre | Ottawa | Ontario | Canada | K1H8L6 |
Sponsors and Collaborators
- Ottawa Hospital Research Institute
Investigators
- Principal Investigator: Michael Vickers, Dr., The Ottawa Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20150853-01H