Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma

NCT05294367 | Recruiting Early Phase 1

• 3 other identifiers: LS20080121-005406P50CA097274
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Improvement in serum magnesium levels

  Will be defined as an increase in magnesium levels of at least 0.2 mg/dL from baseline level or an increase in magnesium level to 2.0 - 2.3 mg/dL at any time after the beginning of replacement.

  Baseline up to 2 cycles (56 days)

Secondary Outcomes (4)

• Feasibility of patient enrollment

  Baseline up to 2 cycles (56 days)

• Tolerability and Toxicity Assessment

  Up to 56 days

• Incidence of adverse events

  Up to 56 days

• Patient compliance

  Up to 56 days

Other Outcomes (2)

• Patient Medication Quality of Life Assessment

  At baseline, 28 days, and 56 days

• Relationship between race/ethnicity and differences in diet and serum magnesium levels

  Up to 56 days

Study Arms (3)

Cycle 1

EXPERIMENTAL

Participants consume magnesium rich foods PO daily for 28 days.

Other: Quality-of-Life Assessment; Behavioral: Special Diet Therapy

Cycle 2, Arm I

EXPERIMENTAL

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

Drug: Magnesium Chloride-based Lotion; Other: Quality-of-Life Assessment; Behavioral: Special Diet Therapy

Cycle 2, Arm II

EXPERIMENTAL

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

Other: Quality-of-Life Assessment; Behavioral: Special Diet Therapy

Interventions

Magnesium Chloride-based Lotion DRUG

Given topically

Also known as: Ancient Minerals Magnesium Lotion, Magnesium Chloride Lotion

Cycle 2, Arm I

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Cycle 1; Cycle 2, Arm I; Cycle 2, Arm II

Special Diet Therapy BEHAVIORAL

Consume magnesium rich foods

Also known as: DIET

Cycle 1; Cycle 2, Arm I; Cycle 2, Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lymphoma

Interventions

Diet

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Thomas E. Witzig, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 24, 2022
• Study Start: April 15, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)