Recruiting
Early Phase 1

Magnesium Replacement

Sponsor:

Mayo Clinic

Code:

NCT05294367

Conditions

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Magnesium Chloride-based Lotion

Quality-of-Life Assessment

Special Diet Therapy

Study Details

Brief summary:

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.

Conditions

Lymphoma

Study ID

NCT05294367

Start date

Apr 15, 2022

Status verified date

Mar, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cycle 1

Participants consume magnesium rich foods PO daily for 28 days.

experimental: Cycle 2, Arm I

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

experimental: Cycle 2, Arm II

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

Interventions

Magnesium Chloride-based Lotion

Given topically

Quality-of-Life Assessment

Ancillary studies

Special Diet Therapy

Consume magnesium rich foods

Primary outcome measure

  • Improvement in serum magnesium levels [ Time Frame: Baseline up to 2 cycles (56 days) ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trial Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Thomas E. Witzig, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-16.