Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy

Feasibility of Dietary Magnesium Replacement for Prevention of Hypomagnesemia in Ovarian Cancer Patients Receiving Carboplatin Chemotherapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ovarian Carcinoma
• Intervention / Treatment: Dietary supplement: Dietary Intervention; Other: Media Intervention; Behavioral: Telephone-Based Intervention

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 supplement: Dietary Intervention; Receive dietary magnesium intervention; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Media Intervention; Undergo video interviews; Behavioral: Telephone-Based Intervention; Receive phone calls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient retention rate	Assessed by percentage of patients completing the dietary intervention. If a patient participated 60% or more of the weekly follow up by the end of the 6th cycle of treatment, she is considered retained. Descriptive statistics (e.g., frequencies, proportions, means, standard deviations [SDs], and ranges), along with 95% confidence intervals (CIs) for the means, will be computed.	Up to 2 years
Dietary adherence rate	Ratio of actual dietary magnesium intake versus the desired 400 mg. Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of hypomagnesemia	Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed.	Up to 2 years
Need for a pharmacy intervention including oral and intravenous magnesium dosage	Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed.	Up to 2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lorenzo Cohen, PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018-1172 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02450 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No