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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

NCT02690012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-09-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Magnesium Oxide

Magnesium Oxide

OTHER

Magnesium Citrate

Magnesium Citrate

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Michael Vickers, Dr. · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02690012 on ClinicalTrials.gov