Magnesium Supplementation for Lymphoma

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must not be taking: Magnesium supplements, Antibiotics

Disqualifiers: Active infection, Kidney disease, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a diet rich in magnesium and a magnesium lotion (Magnesium Chloride-based Lotion) can maintain healthy magnesium levels in people with lymphoma, a type of cancer. The study aims to determine if these natural methods can replace intravenous or oral magnesium supplements. Participants will report any side effects and how these treatments impact their quality of life. Individuals diagnosed with lymphoma who can consume normal table food, including nuts and seeds, might be suitable for this trial. As an Early Phase 1 trial, this research seeks to understand how these natural treatments work in people, offering participants the chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken dedicated magnesium supplements or IV magnesium within 28 days before joining the trial. If you are on a multivitamin with magnesium, you can continue it, but you shouldn't change the brand during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that magnesium treatments, such as lotions and diets, are generally well-tolerated. For instance, Ancient Minerals Magnesium Lotion is designed to be gentle on the skin, absorbing quickly and made with organic oils, making it a popular choice for increasing magnesium levels through the skin.

Consuming magnesium-rich foods is typically easier on the stomach than taking magnesium pills. Additionally, these foods provide other nutrients beneficial for overall health.

This study is in its early stages, focusing primarily on the safety and effectiveness of these treatments. While solid data may be limited, these early tests provide a good starting point. If the lotion and diet have approval for other uses, it suggests they are safe. Overall, these treatments appear quite safe, but the study will help confirm that. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for lymphoma because they explore the potential of magnesium in a completely new way. Unlike traditional chemotherapy and radiation, this approach involves a magnesium-rich diet and a topical magnesium lotion. Magnesium chloride, the active ingredient, is absorbed through the skin, which might offer a gentler and more targeted way to support cell health compared to standard treatments. This method could provide a non-invasive, easily accessible alternative for enhancing patients' quality of life during treatment.

What evidence suggests that magnesium supplementation could be effective for lymphoma?

Research has shown that higher magnesium levels can lead to better outcomes for cancer patients. For those receiving immune checkpoint inhibitors, a type of cancer treatment, higher magnesium levels have been linked to improved results. Magnesium plays a crucial role in maintaining cell health and can help reduce inflammation, which is associated with many diseases. In this trial, participants in different groups will either follow a magnesium-rich diet alone or combine it with a magnesium lotion to increase magnesium levels in the blood. Although the lotion has not been widely studied in lymphoma patients, increasing magnesium could potentially improve health outcomes. ^{2 5 6 7 8}

Who Is on the Research Team?

Thomas E. Witzig, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Adults (18+) with any type of lymphoma can join this trial. Eligible participants include those off myelosuppressive chemotherapy for 2+ months, on certain maintenance or oral therapies, and with an ECOG Performance Status of 0-2. They must not have taken magnesium supplements recently, be able to eat a full diet including seeds/nuts, and have no severe illnesses that could affect the study.

Inclusion Criteria

Ability to complete questionnaire(s) by themselves or with assistance

Magnesium level of 1.5 - 1.9 mg/dL (obtained =< 5 days prior to registration)

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

Receiving any other investigational agent for lymphoma or any other disease

I do not have any severe illnesses that would stop me from following the study's requirements.

Co-morbid systemic illnesses such as active infection or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cycle 1

Participants consume magnesium rich foods orally daily for 28 days

4 weeks

1 visit (in-person) at the end of cycle

Cycle 2

Participants continue consuming magnesium rich foods and may apply magnesium lotion depending on magnesium levels

4 weeks

1 visit (in-person) at the end of cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Chloride-based Lotion
• Special Diet Therapy

Trial Overview The trial is exploring if a magnesium-rich diet and topical magnesium lotion can maintain ideal blood magnesium levels in lymphoma patients. It's an early phase I trial where participants will also help assess side effects and how these forms of magnesium impact their quality of life.

How Is the Trial Designed?

Group I: Cycle 2, Arm II Experimental Treatment 2 Interventions

Participants continue consuming magnesium rich foods PO daily for 28 days.

Group II: Cycle 2, Arm I Experimental Treatment 3 Interventions

Participants continue consuming magnesium rich foods PO daily and apply Ancient Minerals Magnesium Lotion topically daily for 28 days.

Group III: Cycle 1 Experimental Treatment 2 Interventions

Participants consume magnesium rich foods PO daily for 28 days.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 198 individuals with metabolic syndrome and low magnesium levels, those who received magnesium supplementation showed a significant reduction in the prevalence of metabolic syndrome compared to the placebo group (48% vs. 77.5%).

Magnesium supplementation led to notable improvements in key components of metabolic syndrome, including reductions in systolic blood pressure (-3.6 mmHg), diastolic blood pressure (-5.5 mmHg), fasting glucose (-12.4 mg/dL), and triglycerides (-61.2 mg/dL), demonstrating its efficacy in managing metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Magnesium Supplementation and Metabolic Syndrome: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Rodríguez-Morán, M., Simental-Mendía, LE., Gamboa-Gómez, CI., et al.[2019]

Children with acute lymphoblastic leukemia (ALL) showed significantly lower hair magnesium levels compared to healthy controls, particularly in those with T-cell ALL, suggesting a potential link between magnesium deficiency and the disease.

Hair zinc levels were also significantly lower in children with various types of leukemia and lymphoma compared to controls, indicating that chronic zinc deficiency may be associated with the development of these malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High prevelance of chronic magnesium deficiency in T cell lymphoblastic leukemia and chronic zinc deficiency in children with acute lymphoblastic leukemia and malignant lymphoma. Sahin, G., Ertem, U., Duru, F., et al.[2019]

In a study of 581 patients with diffuse large B cell lymphoma undergoing autologous stem cell transplant, 14.1% had low serum magnesium levels (hypomagnesemia), which was linked to poorer survival outcomes.

Patients with hypomagnesemia had significantly shorter event-free survival (3.9 years) and overall survival (7.3 years) compared to those with normal magnesium levels, suggesting that monitoring and addressing magnesium levels could be important for improving prognosis in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypomagnesemia at the time of autologous stem cell transplantation for patients with diffuse large B-cell lymphoma is associated with an increased risk of failure. Gile, JJ., Lopez, CL., Ruan, GJ., et al.[2022]

Physiological oral magnesium supplementation is safe and effective for treating magnesium deficiencies, while pharmacological magnesium therapy can lead to toxicity and should be used cautiously, particularly in acute settings.

Magnesium therapy has specific applications in obstetrics, cardiology, and anesthesia, such as treating eclampsia and certain heart rhythm disorders, but requires careful monitoring to avoid complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium and therapeutics. Durlach, J., Durlach, V., Bac, P., et al.[2017]

The study found that the magnesium content in Burkitt's lymphoma cell lines decreases as the age of the cell culture increases, indicating a potential relationship between cell culture age and magnesium levels.

Using lanthanum oxide during the analysis allowed for the detection of 8 to 40% more magnesium, suggesting that a significant portion of magnesium in these cells is 'bound' and may not be readily available, which could impact cellular functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium variability of lymphocytes from cell culture. Hosseini, JM., Elin, RJ.[2019]

Citations

1. withpower.com withpower.com/trial/early-phase-1-lymphoma-3-2022-57bf1

Magnesium Supplementation for Lymphoma This early phase I trial investigates the effect of dietary and topical magnesium replacement on magnesium blood levels in patients with lymphoma.

2. mayo.edu mayo.edu/research/clinical-trials/cls-20526480

Dietary and Topical Magnesium Replacement or ... The use of this lotion is considered investigational since it hasn't been studied in lymphoma cancer patients with low magnesium levels before; however, the FDA ...

3. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/magnesium-chloride-based-lotion?pn=1

Clinical Trials Using Magnesium Chloride-based Lotion - NCI NCI supports clinical trials that test new and more effective ways to treat cancer. Find clinical trials studying magnesium chloride-based lotion.

4. clinicaltrials.eu clinicaltrials.eu/inn/magnesium-chloride/

Magnesium Chloride: A Versatile Mineral Supplement Researchers are investigating potential benefits such as improved muscle strength and function in stroke patients, better hematologic parameters in thalassemia ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK507261/

Magnesium and cancer: more questions than answers - NCBI Most of the data available suggest that Mg could be a chemo-preventive agent. Therefore, correcting Mg intake might represent an effective and low cost ...

6. ancient-minerals.com ancient-minerals.com/product/magnesium-lotion/

Magnesium Lotion Ancient Minerals Magnesium Lotion is a smooth, quickly absorbed emulsion of magnesium chloride in a skin-nourishing base of certified organic oils.

7. ewg.org ewg.org/skindeep/products/3627331-Ancient_Minerals_Topical_Magnesium_Lotion_NonGreasy_Moisturizing_Lotion_with_Magnesium_Chloride/

Ancient Minerals Topical Magnesium Lotion, Non-Greasy ... EWG's Skin Deep® Cosmetics Database Rating for Ancient Minerals Topical Magnesium Lotion, Non-Greasy Moisturizing Lotion with Magnesium Chloride.

8. ancient-minerals.com ancient-minerals.com/product/magnesium-lotion-ultra/

Magnesium Lotion Ancient Minerals Magnesium Lotion Ultra is a smooth, quickly absorbed emulsion of magnesium chloride in a skin-nourishing base of certified organic oils.