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NCT01867606 · ClinicalTrials.gov registry record · Phase 2
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT01867606: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT01867606 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01867606, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin may help provide nutrition to patients who are not able to eat or digest ordinary food. This may improve the quality of life of patients with gynecological cancer and help them recover more quickly from surgery.
Primary Outcome
For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). The primary analysis will be a comparison of oral SBI vs. placebo using a two-sided log-rank test between the 2 Kaplan-Meier curves.the total score of the 14-item Postoperative Quality of Life (PQL) tool \[15\] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 1
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- OTHER questionnaire administration
- OTHER quality-of-life assessment
- BIOLOGICAL serum-derived bovine immunoglobulin protein isolate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2013-10-04 |
| Est. Completion | 2015-11-21 |
| Phase | Phase 2 |
What the finished NCT01867606 record still lists
NCT01867606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01867606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01867606 about?
NCT01867606 is a clinical study titled "Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery". This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with cancer of the female reproductive tract after undergoing surgery. Serum bovine immunoglobulin may help provide nutrition t...
What is the current status of trial NCT01867606?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2013-10-04. Estimated completion is 2015-11-21.
What interventions are being tested in trial NCT01867606?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), questionnaire administration (OTHER), quality-of-life assessment (OTHER), serum-derived bovine immunoglobulin protein isolate (BIOLOGICAL).
Who is sponsoring clinical trial NCT01867606?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01867606's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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