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NCT05921149 · ClinicalTrials.gov registry record · NA
Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
A NA study, sponsored by Endeavor Health.
- Not yet
- Registry status
- NA
- Development phase
- 170
- Enrollment target
NCT05921149: Clinical Trial NA study, sponsored by Endeavor Health.
NCT05921149 is a NA study that has not yet begun recruiting, run by Endeavor Health. The registered enrollment target is 170 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05921149, a NA study, has not yet begun recruiting, sponsored by Endeavor Health.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 170 participants
- Enrollment target
Study Summary
Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed. Short term fasting protects against toxic effects of chemotherapy without decreasing efficacy. In a prospective clinical trial of breast cancer patients randomized to FMD or regular diet during chemotherapy, less antiemetic was required in the FMD group; radiographic and pathologic responses were better in this group. This trial tests whether platinum-taxane chemotherapy combined with a FMD in advanced and recurrent ovarian, fallopian tube and primary peritoneal cancer patients is associated with decreased toxicity and/ or improved tumor response to therapy.
Primary Outcome
Toxicities and adverse events will be graded and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), v5.0 and will be compared between the two study groups. The following toxicity summaries will be used to compare the diet and non-diet group: Any of the following Grade 2+ GI symptomatic toxicities (nausea and vomiting, anorexia, constipation or diarrhea, mucositis, stomatitis) experienced. The NCI CTCAE has a specific scale (graded 1-5)
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DIETARY_SUPPLEMENT Fasting Mimicking Diet (Xentigen by L'Nutra)
- DIETARY_SUPPLEMENT Standard diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2024-05-25 |
| Est. Completion | 2031-06-01 |
| Phase | NA |
What is known before NCT05921149 opens enrollment
NCT05921149 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT05921149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05921149 about?
NCT05921149 is a clinical study titled "Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer". Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed. Short term fasting protects against toxic effects of chemotherapy without decreasing efficacy. In a prospective clinical trial of breast cancer patients randomized to ...
What is the current status of trial NCT05921149?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 170 participants. The study started on 2024-05-25. Estimated completion is 2031-06-01.
What interventions are being tested in trial NCT05921149?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Fasting Mimicking Diet (Xentigen by L'Nutra) (DIETARY_SUPPLEMENT), Standard diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05921149?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05921149's enrollment target sits among peer trials
170 614th of 2000 higher than 1,382 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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