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Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma

Primary Purpose

Lymphoma

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Magnesium Chloride-based Lotion

Quality-of-Life Assessment

Special Diet Therapy

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cycle 1

Cycle 2, Arm I

Cycle 2, Arm II

Arm Description

Participants consume magnesium rich foods PO daily for 28 days.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Feasibility of patient enrollment

Will be assessed by the percentage of patients that pre-register who continue on to register for the study. Reasons for pre-registering but not continuing on to registration will be summarized descriptively.

Tolerability and Toxicity Assessment

Tolerability and toxicity will be assessed by evaluating the number of days the diet was not properly followed. This will be summarized descriptively.

Incidence of adverse events

Assess the number of doses of topical magnesium replacement missed due to adverse events. Reasons for missed doses will be summarized descriptively.

Patient compliance

Patient compliance with a diet rich in magnesium as well as compliance with topical magnesium replacement will be assessed by evaluating patient medication logs and meal logs. For the magnesium rich diet, a scoring points system will be utilized, where the goal is to achieve 10 points of magnesium in the diet each day. Compliance with the magnesium diet will be defined as meeting at least 7 points daily. For the topical magnesium replacement, the goal is to apply 6 pumps of the lotion daily. Compliance with the topical magnesium replacement will be defined as at least 5 pumps daily. The number of days met for the magnesium rich diet and topical magnesium replacement will be evaluated and summarized descriptively.

Full Information

NCT ID

NCT05294367

First Posted

March 3, 2022

Last Updated

September 25, 2023

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05294367

Brief Title

Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma

Official Title

Pilot Feasibility Trial of Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 15, 2022 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cycle 1

Arm Type

Experimental

Arm Description

Participants consume magnesium rich foods PO daily for 28 days.

Arm Title

Cycle 2, Arm I

Arm Type

Experimental

Arm Description

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

Arm Title

Cycle 2, Arm II

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Magnesium Chloride-based Lotion

Other Intervention Name(s)

Ancient Minerals Magnesium Lotion, Magnesium Chloride Lotion

Intervention Description

Given topically

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Behavioral

Intervention Name(s)

Special Diet Therapy

Other Intervention Name(s)

DIET

Intervention Description

Consume magnesium rich foods

Primary Outcome Measure Information:

Title

Improvement in serum magnesium levels

Description

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.

Time Frame

Baseline up to 2 cycles (56 days)

Secondary Outcome Measure Information:

Title

Feasibility of patient enrollment

Description

Time Frame

Baseline up to 2 cycles (56 days)

Title

Tolerability and Toxicity Assessment

Description

Tolerability and toxicity will be assessed by evaluating the number of days the diet was not properly followed. This will be summarized descriptively.

Time Frame

Up to 56 days

Title

Incidence of adverse events

Description

Assess the number of doses of topical magnesium replacement missed due to adverse events. Reasons for missed doses will be summarized descriptively.

Time Frame

Up to 56 days

Title

Patient compliance

Description

Time Frame

Up to 56 days

Other Pre-specified Outcome Measures:

Title

Patient Medication Quality of Life Assessment

Description

Will be summarized descriptively and changes across time will be explored by patient completing the Quality of Life Assessment Questionairre.

Time Frame

At baseline, 28 days, and 56 days

Title

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

Description

Will be assessed to evaluate whether magnesium replacement strategies are equally effective between racial/ethnic groups. The percentage of patients who achieve an improvement in magnesium levels from baseline will be evaluated in each racial/ethnic group to assess whether differences may exist.

Time Frame

Up to 56 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas E. Witzig, M.D.

Organizational Affiliation

Mayo Clinic in Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Referral Office

Phone

855-776-0015

mayocliniccancerstudies@mayo.edu

First Name & Middle Initial & Last Name & Degree

Thomas E. Witzig, M.D.

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Dietary and Topical Magnesium Replacement or Supplementation in Patients With Lymphoma

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