NCT04310826

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

6.9 years

First QC Date

March 13, 2020

Last Update Submit

February 11, 2026

Conditions

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Occurrence of hypomagnesemia

    Up to 2 years

  • Need for a pharmacy intervention including oral and intravenous magnesium dosage

    Up to 2 years

Study Arms (1)

Prevention (dietary intervention)

EXPERIMENTAL

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 InterventionOther: Media InterventionBehavioral: Telephone-Based Intervention

Interventions

Dietary InterventionDIETARY_SUPPLEMENT

Receive dietary magnesium intervention

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Prevention (dietary intervention)
Media InterventionOTHER

Undergo video interviews

Prevention (dietary intervention)
Telephone-Based InterventionBEHAVIORAL

Receive phone calls

Prevention (dietary intervention)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with previously untreated ovarian cancer.
  • Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles.
  • Able to tolerate an oral diet.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Lorenzo Cohen, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 17, 2020

Study Start

April 23, 2019

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

US(1)