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| ID | Type | Description | Link |
|---|---|---|---|
| 21-005406 | Other Identifier | Mayo Clinic Institutional Review Board | |
| P50CA097274 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycle 1 | Experimental | Participants consume magnesium rich foods PO daily for 28 days. |
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| Cycle 2, Arm I | Experimental | Participants continue consuming magnesium rich foods PO daily and apply Ancient Minerals Magnesium Lotion topically daily for 28 days. |
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| Cycle 2, Arm II | Experimental | Participants continue consuming magnesium rich foods PO daily for 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Chloride-based Lotion | Drug | Given topically |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 2 cycles (56 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 2 cycles (56 days) |
| Tolerability and Toxicity Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Medication Quality of Life Assessment | Will be summarized descriptively and changes across time will be explored by patient completing the Quality of Life Assessment Questionairre. | At baseline, 28 days, and 56 days |
| Relationship between race/ethnicity and differences in diet and serum magnesium levels |
Inclusion Criteria:
PRE-REGISTRATION - INCLUSION CRITERIA:
REGISTRATION - INCLUSION CRITERIA:
Exclusion Criteria:
PRE-REGISTRATION - EXCLUSION CRITERIA:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas E. Witzig, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Special Diet Therapy | Behavioral | Consume magnesium rich foods |
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Tolerability and toxicity will be assessed by evaluating the number of days the diet was not properly followed. This will be summarized descriptively. |
| Up to 56 days |
| 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. | Up to 56 days |
| 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. | Up to 56 days |
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. |
| Up to 56 days |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |