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

Not Applicable

Active, not recruiting

• Conditions: Ovarian Carcinoma

• Registration Number: NCT04310826
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dietary adherence rate	Up to 2 years	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.
Patient retention rate	Up to 2 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States