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NCT05761561 · ClinicalTrials.gov registry record · NA
Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
A NA study of Ovarian Cancer, sponsored by Yale University.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT05761561: Recruiting NA study of Ovarian Cancer, sponsored by Yale University.
NCT05761561 is a NA study of Ovarian Cancer that is actively recruiting participants, run by Yale University. The registered enrollment target is 200 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05761561, a NA study of Ovarian Cancer, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
Study Summary
An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami. Participants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm. Study assessments will be conducted at baseline, post-chemotherapy/end of intervention and at 1-year post diagnosis. Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery. Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.
Primary Outcome
Chemotherapy completion rate will be assessed as the average relative dose intensity for the originally planned regimen based on standard formulas. This will be measured using the number and percent of patients requiring dose-adjustments, dose-delays, reason for dose.
Conditions Studied
Interventions
- BEHAVIORAL Exercise and medical nutrition
Study Locations (2)
Connecticut
- Yale University - New Haven
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-04-19 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT05761561 shows while recruiting
NCT05761561 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which Exercise and medical nutrition is the first listed.
NCT05761561 reports a single indexed study location in Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT05761561 about?
NCT05761561 is a clinical study titled "Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer". An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensiv...
What is the current status of trial NCT05761561?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-04-19. Estimated completion is 2027-06.
What conditions does trial NCT05761561 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT05761561?
The interventions under investigation include: Exercise and medical nutrition (BEHAVIORAL).
Who is sponsoring clinical trial NCT05761561?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05761561 being conducted?
This trial has 2 study locations across Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05761561's enrollment target sits among peer trials
200 98th of 322 higher than 223 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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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