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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2026-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial studies how well a diet high in magnesium works in preventing low blood magnesium levels (hypomagnesemia) in patients with ovarian cancer receiving carboplatin chemotherapy. Hypomagnesemia is a common side effect of carboplatin-containing chemotherapy. A magnesium rich diet may increase the levels of magnesium in the blood and help prevent hypomagnesemia resulting from carboplatin chemotherapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVE:

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type DIETARY_SUPPLEMENT

Receive dietary magnesium intervention

Media Intervention

Intervention Type OTHER

Undergo video interviews

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive phone calls

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary Intervention

Receive dietary magnesium intervention

Intervention Type DIETARY_SUPPLEMENT

Media Intervention

Undergo video interviews

Intervention Type OTHER

Telephone-Based Intervention

Receive phone calls

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with previously untreated ovarian cancer.
* Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles.
* Able to tolerate an oral diet.

Exclusion Criteria

* Prior platinum-based chemotherapy.
* Serum creatinine level \> 1.4 mg/dL prior to treatment.
* Artificial nutrition (e.g. Ensure or Boost) accounts for \> 50% of total calorie intake.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lorenzo Cohen, PHD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer
NCT01439659 ACTIVE_NOT_RECRUITING PHASE2