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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: Recruiting NA study of Advanced Malignant Solid Neoplasm, sponsored by Mayo Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Symptoms will be measured using a modified version of the Memorial Symptom Assessment Scale. The modified version will contain specific items related to side effects of immune checkpoint inhibitors (ICIs) including twelve GI symptoms, skin changes, and fatigue. The scale includes 24 items for which the participant reports on whether a symptom (e.g., pain, lack of energy, shortness of breath) occurred during the previous week, as well as any distress it may have caused. Questions are answered on
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 |
What NCT06438588 shows while recruiting
NCT06438588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06438588's enrollment target sits among peer trials
10 103rd of 108 higher than 5 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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