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

Trial Summary

What is the purpose of this trial?

This early phase I trial investigates the effect of dietary and topical magnesium replacement on magnesium blood levels in patients with lymphoma. Magnesium is an element in the body that is important to cell health. The body cannot make magnesium and it typically comes from the food we eat. In patients who are ill, magnesium is often replaced intravenously (IV) through a vein or by mouth. This study may help researchers find out if being on a magnesium rich diet and using a magnesium lotion on the skin helps to keep magnesium blood levels in an ideal range. This study also investigates side effects and quality of life when receiving different forms of magnesium.

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.

What data supports the effectiveness of the treatment Magnesium Chloride-based Lotion for Lymphoma?

Research suggests that low magnesium levels are common in patients with certain types of lymphoma, and low magnesium is linked to worse outcomes in some lymphoma cases. This implies that magnesium supplementation might help improve these conditions by addressing magnesium deficiency. ^{1 2 3 4 5}

How does magnesium supplementation differ from other treatments for lymphoma?

Magnesium supplementation for lymphoma is unique because it addresses magnesium deficiency, which is linked to poorer outcomes in lymphoma patients, unlike traditional treatments that focus on directly targeting cancer cells. This approach is based on the idea that correcting magnesium levels could improve overall survival and event-free survival in patients, especially those undergoing stem cell transplants. ^{1 2 3 4 5}

Research Team

Thomas E. Witzig, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2019]

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

Magnesium variability of lymphocytes from cell culture. [2019]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Magnesium and therapeutics. [2017]

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

Oral Magnesium Supplementation and Metabolic Syndrome: A Randomized Double-Blind Placebo-Controlled Clinical Trial. [2019]