Dietary and Topical Magnesium Replacement or Supplementation in Patients with Lymphoma
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 21-005406
NCT ID: NCT05294367
Sponsor Protocol Number: LS200801
About this study
The purpose of this research study is to find out if being on a magnesium rich diet and using a magnesium lotion on the skin will help to keep the magnesium blood level in a normal range or increase the magnesium level if it is slightly below the normal range or in the low end of the normal range. We also want to learn about the side effects and quality of life when patients are receiving different forms of magnesium.
Ancient Minerals Magnesium Lotion is an over-the-counter lotion that can be bought at a drug store or on the internet. The use of this lotion is considered investigational since it hasn’t been studied in lymphoma cancer patients with low magnesium levels before; however, the FDA is allowing us to use this lotion in this research study.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
- 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.
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 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 (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.
Registration - Inclusion Criteria:
- The following laboratory value obtained ≤ 5 days prior to registration:
- Magnesium level of 1.5 – 1.9 mg/dL.
Registration - Exclusion Criteria:
Eligibility last updated 11/16/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Thomas Witzig, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available