We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04310826
Recruitment Status : Active, not recruiting
First Posted : March 17, 2020
Last Update Posted : June 24, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Ovarian Carcinoma Dietary Supplement: Dietary Intervention Other: Media Intervention Behavioral: Telephone-Based Intervention Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 23, 2019
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Magnesium

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Patient retention rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310826


Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Lorenzo Cohen, PHD M.D. Anderson Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04310826    
Other Study ID Numbers: 2018-1172
NCI-2019-02450 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-1172 ( Other Identifier: M D Anderson Cancer Center )
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No