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

Not Applicable

Active, not recruiting

Interventions: Dietary Supplement: Dietary Intervention
Other: Media Intervention
Behavioral: Telephone-Based Intervention

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).

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Prevention (dietary intervention)	Media 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).
Prevention (dietary intervention)	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).
Prevention (dietary intervention)	Telephone-Based 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).

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.