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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04310826
Collaborator
National Cancer Institute (NCI) (NIH)
26
Enrollment
1
Location
1
Arm
59.3
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary Intervention
  • Other: Media Intervention
  • Behavioral: Telephone-Based Intervention
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. Evaluate intervention feasibility.
SECONDARY OBJECTIVE:
  1. Evaluate occurrence of hypomagnesemia and the need for a pharmacy regimen including oral and intravenous magnesium dosage.
EXPLORATORY OBJECTIVE:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Feasibility of Dietary Magnesium Replacement for Prevention of Hypomagnesemia in Ovarian Cancer Patients Receiving Carboplatin Chemotherapy
Actual Study Start Date :
Apr 23, 2019
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Secondary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Lorenzo Cohen, PHD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04310826
    Other Study ID Numbers:
    • 2018-1172
    • NCI-2019-02450
    • 2018-1172
    First Posted:
    Mar 17, 2020
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 24, 2022