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Magnesium Supplementation for Lymphoma

Phase < 1
Recruiting
Led By Thomas E. Witzig, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2
Currently have or have had in the past the diagnosis of any type of lymphoma
Must not have
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
Cannot eat normal table food by mouth. NOTE: Patients with any form of feeding tube or a swallowing disorder are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 28 days, and 56 days
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial looks at whether magnesium replacement through diet and a topical lotion can help keep magnesium blood levels ideal in patients with lymphoma. It also investigates side effects and quality of life.

Who is the study for?
Adults (18+) with any type of lymphoma can join this trial. Eligible participants include those off myelosuppressive chemotherapy for 2+ months, on certain maintenance or oral therapies, and with an ECOG Performance Status of 0-2. They must not have taken magnesium supplements recently, be able to eat a full diet including seeds/nuts, and have no severe illnesses that could affect the study.
What is being tested?
The trial is exploring if a magnesium-rich diet and topical magnesium lotion can maintain ideal blood magnesium levels in lymphoma patients. It's an early phase I trial where participants will also help assess side effects and how these forms of magnesium impact their quality of life.
What are the potential side effects?
Potential side effects are not detailed but may include skin reactions from the lotion or digestive changes due to the special diet therapy. The study aims to monitor overall well-being through quality-of-life assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I have been diagnosed with lymphoma at some point.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that would stop me from following the study's requirements.
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I can eat regular food by mouth.
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I have skin lymphoma or rashes that prevent me from testing lotions.
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I do not have severe gut absorption problems or advanced kidney disease.
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I do not have another cancer that needs treatment interfering with this study.
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I have not had major surgery within the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 28 days, and 56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 28 days, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in serum magnesium levels
Secondary study objectives
Feasibility of patient enrollment
Incidence of adverse events
Patient compliance
+1 more
Other study objectives
Patient Medication Quality of Life Assessment
Relationship between race/ethnicity and differences in diet and serum magnesium levels

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cycle 2, Arm IIExperimental Treatment2 Interventions
Participants continue consuming magnesium rich foods PO daily for 28 days.
Group II: Cycle 2, Arm IExperimental Treatment3 Interventions
Participants continue consuming magnesium rich foods PO daily and apply Ancient Minerals Magnesium Lotion topically daily for 28 days.
Group III: Cycle 1Experimental Treatment2 Interventions
Participants consume magnesium rich foods PO daily for 28 days.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,350 Previous Clinical Trials
3,060,614 Total Patients Enrolled
65 Trials studying Lymphoma
27,773 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,024,314 Total Patients Enrolled
1,408 Trials studying Lymphoma
383,414 Patients Enrolled for Lymphoma
Thomas E. Witzig, M.D.Principal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
78 Total Patients Enrolled
2 Trials studying Lymphoma
78 Patients Enrolled for Lymphoma

Media Library

Special Diet Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05294367 — Phase < 1
Lymphoma Research Study Groups: Cycle 1, Cycle 2, Arm I, Cycle 2, Arm II
Lymphoma Clinical Trial 2023: Special Diet Therapy Highlights & Side Effects. Trial Name: NCT05294367 — Phase < 1
Special Diet Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05294367 — Phase < 1
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