Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma

Recruiting now · Early Phase 1

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT05294367

Run by

Mayo Clinic

People needed

60

Starts

2022-04-15

Expected to finish

2027-04-01

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• PRE-REGISTRATION - INCLUSION CRITERIA:
• Age >= 18 years
• Currently have or have had in the past the diagnosis of any type of lymphoma
• If previously treated, the patient must be off myelosuppressive chemotherapy with no planned chemotherapy for >= 2 months. Patients with lymphoproliferative disorders being observed (i.e., never treated) or those on rituximab (or equivalent) maintenance or chronic oral therapies such as BTK inhibitors, venetoclax, tazemetostat, or corticosteroids are also eligible
• Able to eat a full range of solid food and liquids and tolerate seeds/nuts
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2
• Provide written informed consent
• Able to recollect dietary intake for the prior 24 hours in order to complete a one-day food record with assistance from a dietitian at each study visit
• Willing to be seen at the enrolling institution at baseline, and at 4 weeks and 8 weeks (end of treatment) in person or by video/phone
• Willing to have a blood magnesium checked every 2 weeks x 4 at any Mayo Clinic site
• Ability to complete questionnaire(s) by themselves or with assistance
• REGISTRATION - INCLUSION CRITERIA:
• Magnesium level of 1.5 - 1.9 mg/dL (obtained =< 5 days prior to registration)

You may not qualify if…

• PRE-REGISTRATION - EXCLUSION CRITERIA:
• Cannot eat normal table food by mouth. NOTE: Patients with any form of feeding tube or a swallowing disorder are not eligible
• Have taken dedicated magnesium supplements (i.e. magnesium oxide) or intravenous (IV) magnesium =< 28 days prior to pre-registration. Note: If patient is already on a multivitamin containing -magnesium, they may be enrolled, but the brand should not be changed during the 8 weeks on study
• 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
• Patients with significant gut malabsorptive conditions (such as inflammatory bowel disease or others at the discretion of the investigator) will be excluded as well as patients with chronic kidney disease stage 3b or greater (estimated glomerular filtration rate [eGFR] < 45)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent for lymphoma or any other disease
• Active other malignancy requiring treatment that would interfere with the assessments of this study
• Major surgery other than diagnostic surgery =< 4 weeks prior to pre-registration
• Have an allergy to nuts
• Patients with active skin lymphoma or rashes that would preclude lotion testing
• Have taken antibiotics =< 7 days prior to pre-registration

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.