Dietary Magnesium for Ovarian Cancer Patients on Chemotherapy

Overseen By Wenli Liu

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior platinum chemotherapy, High creatinine, Artificial nutrition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a magnesium-rich diet can prevent low blood magnesium levels, a common issue for ovarian cancer patients undergoing chemotherapy with carboplatin. Low magnesium often results from this treatment, and increasing dietary magnesium might help avoid it. Participants will receive guidance on eating magnesium-rich foods through weekly calls with a dietitian or healthcare provider. This trial targets individuals with untreated ovarian cancer who can eat normally and are beginning at least six cycles of carboplatin chemotherapy. As an unphased trial, it offers participants the chance to contribute to research that could enhance dietary guidelines for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that a diet high in magnesium is safe for ovarian cancer patients on chemotherapy?

Research has shown that eating foods high in magnesium might help raise magnesium levels in the blood for patients with ovarian cancer. Magnesium, found in many foods like nuts and leafy greens, is important because chemotherapy, especially with carboplatin, can lower magnesium levels, leading to hypomagnesemia.

Studies have found that patients who ate a diet rich in magnesium increased their magnesium intake. This suggests the diet is easy to follow and can help prevent low magnesium levels. No serious side effects have been reported from eating a magnesium-rich diet. However, more research is needed to fully understand its long-term health effects.

Overall, increasing magnesium through diet appears to be a safe option for those undergoing chemotherapy for ovarian cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about dietary magnesium for ovarian cancer patients on chemotherapy because it offers a unique, non-drug approach to potentially improve patient outcomes. Unlike traditional chemotherapy treatments, which often involve medications with significant side effects, this intervention focuses on a simple dietary change that could enhance the body's resilience during chemotherapy. By providing a natural mineral through diet, combined with personalized support from dietitians, it aims to support overall health and possibly reduce treatment-related discomfort, making it a promising complementary strategy.

What evidence suggests that dietary magnesium is effective for preventing hypomagnesemia in ovarian cancer patients on chemotherapy?

Research shows that eating foods rich in magnesium might help prevent low magnesium levels, known as hypomagnesemia, in ovarian cancer patients receiving carboplatin chemotherapy. Past studies found that many of these patients lacked sufficient magnesium in their diet. By increasing magnesium intake, they could maintain healthy magnesium levels. Preventing hypomagnesemia might also enhance overall health and possibly improve treatment response. In this trial, participants will receive a dietary magnesium intervention, offering a simple and natural way to manage a common side effect of chemotherapy. ^{1 2 3 4 5}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to tolerate an oral diet.

I have ovarian cancer that has not been treated yet.

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

Exclusion Criteria

Serum creatinine level > 1.4 mg/dL prior to treatment.

Artificial nutrition (e.g. Ensure or Boost) accounts for > 50% of total calorie intake.

I have received platinum-based chemotherapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a dietary magnesium intervention consisting of a food reference list and weekly phone calls or video interviews for up to the 6th cycle of chemotherapy

15 weeks

Weekly phone calls or video interviews

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the occurrence of hypomagnesemia and need for pharmacy intervention

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Magnesium

Trial Overview 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.

How Is the Trial Designed?

Group I: Prevention (dietary intervention) Experimental Treatment 3 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).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12337152/

Dietary magnesium replacement for prevention of ... The current study assessed the feasibility of dietary replacement of magnesium for prevention of hypomagnesemia in patients with ovarian cancer receiving ...

2. ascopubs.org ascopubs.org/doi/abs/10.1200/OP.23.00660

Dietary Magnesium Replacement for Prevention of ... We conducted a prospective feasibility study of magnesium-rich diets in patients 18 years and older with previously untreated ovarian cancer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6656478/

Hypomagnesemia and Survival in Patients with Ovarian ... This article examines the association between hypomagnesemia and survival in patients who underwent chemotherapy regimens containing carboplatin for ovarian ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04310826

Study Details | NCT04310826 | Dietary Magnesium in ... This trial studies how well a diet high in magnesium works in preventing low blood magnesium levels (hypomagnesemia) in patients with ovarian cancer receiving ...

5. oncologynurseadvisor.com oncologynurseadvisor.com/news/dietary-magnesium-replacement-prevents-chemotherapy-treatment-risk/

Dietary Magnesium Replacement Prevents Chemotherapy ... The average dietary magnesium intake was 100.53 mg/day at baseline, and only 6% of patients achieved an intake of at least 280 mg. Patients ...