Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy
NCT ID: NCT04310826
Last Updated: 2025-08-12
Study Results
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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ACTIVE_NOT_RECRUITING
NA
26 participants
INTERVENTIONAL
2019-04-23
2026-04-01
Brief Summary
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Detailed Description
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I. Evaluate intervention feasibility.
SECONDARY OBJECTIVE:
I. Evaluate occurrence of hypomagnesemia and the need for a pharmacy regimen including oral and intravenous magnesium dosage.
EXPLORATORY OBJECTIVE:
I. Explore changes in other electrolytes, weight, and occurrence of chemotherapy delay or discontinuation and hospitalization which can be related to dietary intervention and program completion.
OUTLINE:
Patients receive a dietary magnesium intervention consisting of a food reference list and phone calls or video interviews from a registered dietitian, integrative medicine physician, or a mid-level provider over 10-20 minutes once a week for up to the 6th cycle of chemotherapy (average 15 weeks).
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Prevention (dietary intervention)
Patients receive a dietary magnesium intervention consisting of a food reference list and phone calls or video interviews from a registered dietitian, integrative medicine physician, or a mid-level provider over 10-20 minutes once a week for up to the 6th cycle of chemotherapy (average 15 weeks).
Dietary Intervention
Receive dietary magnesium intervention
Media Intervention
Undergo video interviews
Telephone-Based Intervention
Receive phone calls
Interventions
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Dietary Intervention
Receive dietary magnesium intervention
Media Intervention
Undergo video interviews
Telephone-Based Intervention
Receive phone calls
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles.
* Able to tolerate an oral diet.
Exclusion Criteria
* Serum creatinine level \> 1.4 mg/dL prior to treatment.
* Artificial nutrition (e.g. Ensure or Boost) accounts for \> 50% of total calorie intake.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lorenzo Cohen, PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-02450
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-1172
Identifier Type: OTHER
Identifier Source: secondary_id
2018-1172
Identifier Type: -
Identifier Source: org_study_id
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