Magnesium supplementation for lymphoma patients
Pilot Feasibility Trial of Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma
This study tests if eating magnesium-rich foods and using a magnesium lotion can improve magnesium levels and quality of life for people with lymphoma.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | rituximab, chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05294367 on ClinicalTrials.gov |
What this trial studies
This early phase I trial investigates the effects of dietary and topical magnesium replacement on serum magnesium levels in patients with lymphoma. Participants will consume magnesium-rich foods and apply a magnesium lotion to assess improvements in magnesium levels, compliance, and quality of life. The study aims to evaluate the tolerability and side effects of these interventions while exploring their effectiveness across different ethnicities. Patients will be monitored over two cycles, with specific criteria for continuation based on their magnesium levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of lymphoma who are not currently undergoing myelosuppressive chemotherapy.
Not a fit: Patients currently receiving active chemotherapy or those with magnesium levels above the study's specified range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve magnesium levels and overall quality of life for lymphoma patients.
How similar studies have performed: While magnesium supplementation has been explored in various contexts, this specific approach in lymphoma patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Thomas E. Witzig, M.D. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.