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

NCT02690012 | Completed

• 1 other identifier: 20150853-01H
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypomagnesemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Magnesium levels

  One year

• Cardiac risk

  one year

• Cost factors

  one year

• Rates of treatment delays

  one year

• Rates of hospital admissions.

  One year

Study Arms (2)

Drug Magnesium oxide

ACTIVE COMPARATOR

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

Other: Magnesium Oxide

Drug Magnesium citrate

ACTIVE COMPARATOR

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

Other: Magnesium Citrate

Interventions

Magnesium Oxide OTHER

Magnesium Oxide

Drug Magnesium oxide

Magnesium Citrate OTHER

Magnesium Citrate

Drug Magnesium citrate

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Interventions

Magnesium Oxide; magnesium citrate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Michael Vickers, Dr.

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 24, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

CA (1)