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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-03-31

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.

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Detailed Description

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Conditions

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Hypomagnesemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Drug Magnesium oxide

Participants will be given standard dose levels of Magnesium oxide according to the level of magnesium in blood.

Group Type ACTIVE_COMPARATOR

Magnesium Oxide

Intervention Type OTHER

Magnesium Oxide

Drug Magnesium citrate

Participants will be given standard dose levels of Magnesium citrate according to the level of magnesium in blood.

Group Type ACTIVE_COMPARATOR

Magnesium Citrate

Intervention Type OTHER

Magnesium Citrate

Interventions

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Magnesium Oxide

Intervention Type OTHER

Magnesium Citrate

Intervention Type OTHER

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).

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No