Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
NCT ID: NCT01867606
Last Updated: 2025-04-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2013-10-04
2015-11-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
NCT04567771
Collecting Tumor Samples From Patients With Gynecological Tumors
NCT00897442
Glycoprotein and Glycan in Tissue and Blood Samples of Patients With Stage IB-IVA Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes
NCT00460356
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
NCT01079832
Gyn Onc Prehab Study
NCT04298827
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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) vs. placebo.
SECONDARY OBJECTIVES:
I. To compare the surgical complication rates between oral SBI vs. placebo up to 1 month post-surgery (safety endpoint).
II. To compare the QOL, as derived from the previously-validated Symptom Distress Scale, the Postoperative Quality of Life questionnaire (PQL), and the uniscale (overall QOL item) between patients receiving oral SBI vs. placebo.
III. To compare the grade 2 or worse adverse event rates for patients receiving oral SBI vs. placebo.
IV. To characterize the adverse event profile of oral SBI in postoperative gynecological cancer patients (safety endpoint).
V. To compare supplement adherence between patients receiving oral SBI vs. placebo.
TERTIARY OBJECTIVES:
I. To explore whether candidate biomarkers are modified with SBI versus placebo.
II. As part of ongoing research, to bank leftover blood samples for future studies.
III. To explore quality of life during postoperative recovery after gynecologic surgery, regardless of whether or not patients take the study intervention/placebo or discontinue intervention/placebo early.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive SBI orally (PO) twice daily (BID) on days 1-28.
ARM II: Patients receive placebo PO BID on days 1-28.
In both arms, treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I (serum-derived bovine immunoglobulin protein isolate)
Patients receive SBI PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
serum-derived bovine immunoglobulin protein isolate
Given PO
laboratory biomarker analysis
Correlative studies
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Arm II (placebo)
Patients receive placebo PO BID on days 1-28.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
placebo
Given PO
laboratory biomarker analysis
Correlative studies
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
serum-derived bovine immunoglobulin protein isolate
Given PO
placebo
Given PO
laboratory biomarker analysis
Correlative studies
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aminah Jatoi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2013-00866
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1267
Identifier Type: OTHER
Identifier Source: secondary_id
12-009448
Identifier Type: OTHER
Identifier Source: secondary_id
MC1267
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.