Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-009448
NCT ID: NCT01867606
Sponsor Protocol Number: MC1267
About this study
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 gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Diagnosis of gynecological cancer of any type or strong suspicion for cancer
- Patients must have begun postoperative oral intake of food prior to registration
- An open laparotomy, cancer therapeutic surgery (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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Aminah Jatoi, M.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office