Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies (OTT 15-03)

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.

Study Overview

• Status: Completed
• Conditions: Hypomagnesemia
• Intervention / Treatment: Other: Magnesium Oxide; Other: Magnesium Citrate

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H8L6
      • The Ottawa Hospital Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Michael Vickers, Dr., The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Cathartics; Antacids; Magnesium Oxide; Magnesium citrate
• Other Study ID Numbers: 20150853-01H