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NCT06438588 · ClinicalTrials.gov registry record · NA
Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial
A NA study of Advanced Malignant Solid Neoplasm, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06438588 is a NA study of Advanced Malignant Solid Neoplasm that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 10 participants, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06438588, a NA study of Advanced Malignant Solid Neoplasm, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial assesses an effective and translatable care model to understand and reduce the adverse effects that cancer patients experience during their treatment therapies and thereby enhance their well-being and quality of life. Excessive immune activation can affect multiple organs with the most common adverse effects being skin rash, diarrhea, colitis, fatigue, hypothyroidism and anorexia. A restrictive calorie diet, mostly of fat and complex carbohydrates, will mimic fasting and increase resiliency to protect patients from the adverse effects of cancer treatments, by managing the adverse side effects of immune checkpoint inhibitors (ICI) treatments in select cancer patients. The fast mimicking diet (FMD) (Xentigen®) is a calorie restrictive, low-calorie, low-protein, high complex carbohydrate, high-fat diet. The FMD program is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients which are generally regarded as safe (GRAS) and comprises mainly of vegetable-based soups and broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. Following a FMD may reduce the adverse effects that some cancer patients experience while following immunotherapy treatments.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Educational Intervention
- OTHER Electronic Health Record Review
- OTHER Dietary Intervention
- OTHER Interview
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-03-06 |
| Est. Completion | 2027-03-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06438588
The ClinicalTrials.gov registry entry for NCT06438588 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (94% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06438588 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06438588 about?
NCT06438588 is a clinical study titled "Fasting Mimicking Diet for Reducing Immune Related Adverse Events for Cancer Patients on Immune Checkpoint Inhibitors, FMD-ICI Trial". This clinical trial assesses an effective and translatable care model to understand and reduce the adverse effects that cancer patients experience during their treatment therapies and thereby enhance their well-being and quality of life. Excessive immune activation can affect multiple organs with th...
What is the current status of trial NCT06438588?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2024-03-06. Estimated completion is 2027-03-15.
What conditions does trial NCT06438588 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm.
What interventions are being tested in trial NCT06438588?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Educational Intervention (OTHER), Electronic Health Record Review (OTHER), Dietary Intervention (OTHER), Interview (OTHER).
Who is sponsoring clinical trial NCT06438588?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06438588 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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