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

Ovarian Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04310826
• Other study ID #: 2018-1172
• Secondary ID: NCI-2019-0245020
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Carcinoma

Intervention

Dietary Supplement:
• Dietary Intervention
Receive dietary magnesium intervention

Other:
• Media Intervention
Undergo video interviews

Behavioral:
• Telephone-Based Intervention
Receive phone calls

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

•   MD Anderson Cancer Center Website