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

26 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Dietary Magnesium for ovarian cancer patients on chemotherapy?

Research suggests that magnesium supplements can help reduce kidney damage in cancer patients receiving chemotherapy, and higher magnesium intake has been linked to better survival rates in breast cancer patients. This indicates that magnesium might offer benefits for ovarian cancer patients undergoing chemotherapy as well. ^{1 2 3 4 5}

Is dietary magnesium safe for humans, especially for cancer patients on chemotherapy?

Research shows that magnesium supplements, both oral and intravenous, are generally safe for cancer patients undergoing chemotherapy. Some patients may experience mild gastrointestinal symptoms like nausea and diarrhea, but no serious side effects have been reported. ^{1 2 3 6 7}

How does dietary magnesium differ from other treatments for ovarian cancer patients on chemotherapy?

Dietary magnesium is unique because it aims to address hypomagnesemia (low magnesium levels) caused by chemotherapy drugs like carboplatin and cisplatin, which can lead to kidney damage and other side effects. Unlike standard chemotherapy, magnesium supplementation focuses on reducing these side effects and improving overall treatment tolerance. ^{1 2 3 8 9}

What is the purpose of this trial?

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.

Research Team

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Hypomagnesemia and Survival in Patients with Ovarian Cancer Who Received Chemotherapy with Carboplatin. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Effects of magnesium supplementation in testicular cancer patients receiving cis-platin: a randomised trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Renal protection with magnesium subcarbonate and magnesium sulphate in patients with epithelial ovarian cancer after cisplatin and paclitaxel chemotherapy: a randomised phase II study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Oral magnesium supplements for cancer treatment-induced hypomagnesemia: Results from a pilot randomized trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Associations of intakes of magnesium and calcium and survival among women with breast cancer: results from Western New York Exposures and Breast Cancer (WEB) Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Intravenous and oral magnesium supplementations in the prophylaxis of cisplatin-induced hypomagnesemia. Results of a controlled trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Magnesium depletion in patients receiving cisplatin-based chemotherapy. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Hypomagnesemia in patients of gynecologic neoplasms following chemotherapy with cisplatin]. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Pre-diagnostic dietary consumption of calcium and magnesium and calcium-to-magnesium intake ratio and ovarian cancer mortality: results from the ovarian cancer follow-up study (OOPS). [2022]