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Dietary Magnesium for Ovarian Cancer Patients on Chemotherapy

N/A

Waitlist Available

Led By Wenli Liu

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with previously untreated ovarian cancer.

Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing whether a diet high in magnesium can help prevent a common side effect of carboplatin chemotherapy called low blood magnesium levels (hypomagnesemia).

Who is the study for?

This trial is for patients with untreated ovarian cancer who can eat normally and are set to receive at least 6 cycles of carboplatin chemotherapy. It's not for those with high serum creatinine levels, rely heavily on artificial nutrition like Ensure or Boost, or have had platinum-based chemotherapy before.Check my eligibility

What is being tested?

The study is testing if a diet rich in magnesium can prevent low blood magnesium levels caused by carboplatin chemotherapy in ovarian cancer patients. Participants will follow dietary guidelines, use media resources, and have phone support to help them stick to the diet.See study design

What are the potential side effects?

While this trial focuses on dietary changes rather than drugs, potential side effects may include digestive discomfort from increasing magnesium intake too quickly. However, these are generally mild compared to medication side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have ovarian cancer that has not been treated yet.

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I am undergoing a chemotherapy regimen that includes carboplatin for 6 or more cycles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dietary adherence rate

Patient retention rate

Secondary outcome measures

Magnesium

Occurrence of hypomagnesemia

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (dietary intervention)Experimental Treatment3 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Intervention

2014

Completed Phase 2

~2550

Telephone-Based Intervention

2017

Completed Phase 2

~3400

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,755 Total Patients Enrolled

47 Trials studying Ovarian Cancer

16,745 Patients Enrolled for Ovarian Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,127 Total Patients Enrolled

286 Trials studying Ovarian Cancer

73,766 Patients Enrolled for Ovarian Cancer

Wenli LiuPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

70 Total Patients Enrolled

Media Library

Dietary Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04310826 — N/A

Ovarian Cancer Research Study Groups: Prevention (dietary intervention)

Ovarian Cancer Clinical Trial 2023: Dietary Intervention Highlights & Side Effects. Trial Name: NCT04310826 — N/A

Dietary Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04310826 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it currently possible to enroll in this clinical investigation?

"Clinicaltrials.gov shows that patient recruitment for this medical trial has been concluded, having first gone live on April 23rd 2019 and last updated on June 23rd 2022. Nevertheless, 41 other studies are still open to participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04310826.