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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Ovarian Carcinoma

Treatments: Dietary Supplement: Dietary Intervention; Behavioral: Telephone-Based Intervention; Other: Media Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04310826

NCI-2019-02450 (Registry Identifier)

2018-1172

Details and patient eligibility

About

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.

Full 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).

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Prevention (dietary intervention)

Experimental group

Description:

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).

Treatment:

Other: Media Intervention

Behavioral: Telephone-Based Intervention

Dietary Supplement: Dietary Intervention