Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma

Last updated: April 16, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Treatment

Special Diet Therapy

Magnesium Chloride-based Lotion

Quality-of-Life Assessment

Clinical Study ID

NCT05294367
LS200801
P30CA015083
P50CA097274
NCI-2022-00602
21-005406
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 noplanned chemotherapy for >= 2 months. Patients with lymphoproliferative disordersbeing 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 aone-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 8weeks (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

Exclusion Criteria:

PRE-REGISTRATION - EXCLUSION CRITERIA:

  • Cannot eat normal table food by mouth. NOTE: Patients with any form of feeding tubeor 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 ona multivitamin containing -magnesium, they may be enrolled, but the brand should notbe changed during the 8 weeks on study

  • Co-morbid systemic illnesses such as active infection or other severe concurrentdisease which, in the judgment of the investigator, would make the patientinappropriate for entry into this study or interfere significantly with the properassessment of safety and toxicity of the prescribed regimens

  • Patients with significant gut malabsorptive conditions (such as inflammatory boweldisease or others at the discretion of the investigator) will be excluded as well aspatients with chronic kidney disease stage 3b or greater (estimated glomerularfiltration rate [eGFR] < 45)

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris,uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that wouldlimit compliance with study requirements

  • Receiving any other investigational agent for lymphoma or any other disease

  • Active other malignancy requiring treatment that would interfere with theassessments 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

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Special Diet Therapy
Phase: 1
Study Start date:
April 15, 2022
Estimated Completion Date:
April 01, 2027

Study Description

PRIMARY OBJECTIVE:

I. Assess if dietary replacement with magnesium rich foods and topical magnesium replacement improves serum magnesium levels in patients with a history of a lymphoproliferative disorder, not on active myelosuppressive chemotherapy, and have a serum magnesium levels 1.5 - 1.9 mg/dL.

SECONDARY OBJECTIVES:

I. Evaluate the compliance of a diet rich in magnesium as well as compliance with topical magnesium replacement in lymphoma patients who have completed therapy and are in remission.

II. Assess feasibility of enrolling patients with a history of lymphoproliferative disorder, not on active treatment with low magnesium levels.

III. Assess tolerability and toxicity of a magnesium rich diet with and without topical magnesium replacement.

EXPLORATORY OBJECTIVES:

I. Assess quality of life in patients receiving magnesium replacement with diet and/or topical magnesium.

II. Evaluate whether magnesium replacement strategies are equally effective between ethnicities.

OUTLINE:

CYCLE 1: Participants consume magnesium rich foods orally (PO) daily for 28 days.

CYCLE 2: Participants with a magnesium level between 1.5-2.1 mg/dL at the end of cycle 1 are assigned to Arm I. Patients with a magnesium level between 2.2-2.3 mg/dL at the end of cycle 1 are assigned to Arm II. Patients with a magnesium level < 1.5 mg/dL at the end of cycle 1 go off study.

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

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

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.