A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM)
- Conditions
- Multiple Myeloma, Smoldering
- Registration Number
- NCT06055894
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br> - Confirmed prior diagnosis of smoldering myeloma (anytime prior). However,<br> confirmation of SMM diagnosis must be documented in their last local oncologist<br> clinic note within 6 months prior to study enrollment.<br><br> - Age =18 years<br><br> - Willingness to comply with all study-related procedures<br><br> - Physically able to complete requirements for the study or has someone to assist with<br> the requirements (such as meal preparation, stool shipment and survey completion)<br><br> - Interested in learning to cook plant based recipes<br><br> - Access to smart mobile phone or device with camera and ability to download Keenoa<br> app<br><br> - Be residing within the United States for the study duration.<br><br> - English speaking or a family member or caregiver who speaks English and is able to<br> assist with the surveys and phone based Keenoa app.<br><br>Exclusion Criteria:<br><br> - Taking any supplements other than vitamin D, iron, vitamin B12, potassium,<br> magnesium, calcium or those needed for a medical indication must be reviewed by PI.<br> If patient is on a supplement (including curcumin, probiotic, omega3) they must stop<br> these for 2 weeks prior to enrollment on study.<br><br> - Patients that already follow a whole foods plant based diet (ovo-lactovegetarian or<br> processed junk food vegan diets are not excluded). This will be per research<br> dietitian evaluation and discretion after nutrition screening.<br><br> - Legume allergy<br><br> - Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as<br> cashews<br><br> - Concurrent participation in weight loss/dietary trials or defined programs (that<br> require specified diets/supplements on the program)<br><br> - Concurrent use of prescription weight loss (such as semaglutides and tirzepatides)<br> and/or therapeutic myeloma drugs such as daratumumab, lenalidomide, etc.) within 12<br> weeks of consent<br><br> - Mental impairment leading to inability to cooperate<br><br> - Enrollment onto any other therapeutic investigational study<br><br> - Concurrent pregnancy<br><br> - Patients on full dose anticoagulation<br><br> - = Grade 2 electrolyte (sodium and potassium) abnormalities as defined by CTCAEv5.0<br> (need to be resolved before enrolling on study)<br><br> - If in the opinion of the investigator there maybe any concerns regarding the ability<br> of the patient to complete the study safely<br><br> - Current self reported heavy alcohol use (defined as >2 drinks per day or >14 drinks<br> per week)<br><br> - Current self-reported illicit drug use (except inhaled marijuana, vaping or<br> cigarette smoking. Oral marijuana/THC excluded or must stop >2 weeks prior.)<br><br> - Has a condition requiring antibiotics within 14 days of study intervention<br> administration.<br><br> - Plan for travel during the study that would preclude adherence to prescribed diets<br><br> - History of active inflammatory bowel disease or major gastrointestinal surgery (not<br> including appendectomy or cholecystectomy) within 3 months of enrollment or any<br> history of total colectomy, or bariatric surgery (bariatric surgery which does not<br> disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are<br> permitted)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative abundance of stool butyrate producers at 2 weeks
- Secondary Outcome Measures
Name Time Method