Status:
COMPLETED
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Lead Sponsor:
Mayo Clinic
Conditions:
Female Reproductive Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 r...
Detailed Description
PRIMARY OBJECTIVES: I. To compare the time-to-quality of life (QOL) improvement from baseline in postoperative gynecological cancer patients who are receiving oral serum bovine immunoglobulin (SBI) v...
Eligibility Criteria
Inclusion
- Diagnosis of gynecological cancer of any type or strong suspicion for cancer
- Patients must have begun postoperative oral intake of food prior to registration
- Open laparotomy or laparoscopic surgery undertaken with cancer therapeutic intent (not a subsequent surgery to manage a postoperative complication) that had occurred =\< 7 days prior to registration and that entailed more than a simple hysterectomy
- Creatinine =\< 1.5 x the upper limit of normal (ULN)
- Absolute neutrophil count \>= 1500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide informed written consent
- Negative (serum) pregnancy test done =\< 7 days prior to randomization, for women of childbearing potential only
- Willing to provide mandatory baseline blood samples for correlative research purposes
Exclusion
- Symptomatic and/or untreated brain metastases
- Ongoing parenteral nutrition (receiving intravenous nutrition support at the time of enrollment); note: patients may be receiving maintenance intravenous (IV) fluids
- Current enrollment in any other trial that entails the concurrent administration of any other agent designed to enhance postoperative recovery
- Allergy to beef
Key Trial Info
Start Date :
October 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2015
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01867606
Start Date
October 4 2013
End Date
November 21 2015
Last Update
April 1 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905