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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 28 days, and 56 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with lymphoma at some point.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 28 days, and 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 28 days, and 56 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in serum magnesium levels
Secondary outcome measures
Feasibility of patient enrollment
Incidence of adverse events
Patient compliance
+1 moreOther outcome measures
Patient Medication Quality of Life Assessment
Relationship between race/ethnicity and differences in diet and serum magnesium levels
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
3,221 Previous Clinical Trials
3,767,892 Total Patients Enrolled
63 Trials studying Lymphoma
27,995 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,927,245 Total Patients Enrolled
1,387 Trials studying Lymphoma
382,509 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that would stop me from following the study's requirements.I can take care of myself and am up and about more than half of my waking hours.I have been diagnosed with lymphoma at some point.I have taken antibiotics within the last 7 days.I am 18 years old or older.I can eat regular food by mouth.I can attend appointments in person or via video/phone at the start, 4 weeks, and 8 weeks.I haven't taken magnesium supplements or IV magnesium in the last 28 days.I haven't had chemotherapy that lowers blood cell counts in the last 2 months.I have skin lymphoma or rashes that prevent me from testing lotions.I do not have severe gut absorption problems or advanced kidney disease.I do not have another cancer that needs treatment interfering with this study.I have not had major surgery within the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Cycle 1
- Group 2: Cycle 2, Arm I
- Group 3: Cycle 2, Arm II
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are involved in this research study?
"Affirmative. Information posted on clinicaltrials.gov states that this clinical trial commenced recruitment on April 15th 2022 and is still actively seeking participants. The study will accept 50 patients at one location."
Answered by AI
Does this clinical investigation have any open spots for enrollment at present?
"Clinicaltrials.gov's repository of information indicates that this experiment is currently seeking participants, having been posted on April 15th and updated most recently on the 18th of the same month."
Answered by AI
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