Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT05294367
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Pilot Feasibility Trial of Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-00602 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 21-005406 | OTHER | Mayo Clinic Institutional Review Board | View | |
| P50CA097274 | NIH | None | https://reporter.nih.gov/quic… | View |