HypomagnesemiaOTT 15-03NCT02690012
Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies
A study testing Magnesium Oxide and Magnesium Citrate in people with Hypomagnesemia, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypomagnesemia
- What is being tested?
- Magnesium Oxide and Magnesium Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Magnesium Oxide, Magnesium Citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium OxideOther
Magnesium Oxide
Magnesium CitrateOther
Magnesium Citrate
| Study group | Role | What they receive |
|---|---|---|
| Drug Magnesium oxide | Active comparator | Participants will be given standard dose levels of Magnesium oxide according to the level of magnesium in blood. Receives: 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. Receives: Other: Magnesium Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who are eligible and agree to participate in RCT.
Measured: one year
Percentage of medical oncologists who agree to participate in the study at study commencement and approach patients for the study.
Measured: one year
Secondary outcomes (5)
Magnesium levels
Compare the differences in levels of magnesium between the two regimens
Measured: 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.
Measured: one year
Cost factors
Determine cost differences between two magnesium replacement strategies.
Measured: one year
Rates of treatment delays
Measured: one year
Rates of hospital admissions.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypomagnesemiaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Vickers, Dr., Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690012
- Sponsor's protocol ID
- 20150853-01H
- Acronym
- OTT 15-03
- Status last verified
- Sep 2019
- First submitted
- 27 Jan 2016
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for the Management of Hypomagnesemia From Anti-Cancer Therapies
- ClinicalTrials.gov ID
- NCT02690012
- Acronym / sponsor ID
- OTT 15-03 / 20150853-01H
- Conditions
- Hypomagnesemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Magnesium oxide | Active comparator | Other: Magnesium OxideParticipants will be given standard dose levels of Magnesium oxide according to the level of magnesium in blood. |
| Drug Magnesium citrate | Active comparator | Other: Magnesium CitrateParticipants will be given standard dose levels of Magnesium citrate according to the level of magnesium in blood. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Palliative-intent treatment with Cisplatin, Carboplatin, Panitumumab or Cetuximab and expected to receive ≥ 2 months of further therapy.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium OxideMagnesium Oxide | Other | Drug Magnesium oxide |
| Magnesium CitrateMagnesium Citrate | Other | Drug Magnesium citrate |
Primary outcome
Percentage of participants who are eligible and agree to participate in RCT.
Time frame: one year
Percentage of medical oncologists who agree to participate in the study at study commencement and approach patients for the study.
Time frame: one year
5 secondary outcomes
Magnesium levels
Time frame: One year
Cardiac risk
Time frame: one year
Cost factors
Time frame: one year
Rates of treatment delays
Time frame: one year
Rates of hospital admissions.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Related trials for Hypomagnesemia
Active, not recruiting
Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy
Ovarian Carcinoma
Not yet recruiting
Magnesium Supplementation as a Nutritional Intervention in Sarcopenia
Sarcopenia
RecruitingObservational study
The Study of Urinary Biomarkers in Patients With Hypomagnesemia
Hypomagnesemia
RecruitingPhase 4
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Hypomagnesemia
Not yet recruitingPhase 2
MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
Hypomagnesemia in Type 2 Diabetic Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Vickers, Dr. principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Oxide and Magnesium Citrate in people with Hypomagnesemia, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who are eligible and agree to participate in RCT. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.