Clinical trial · Interventional
Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
MC1267, A Randomized, Blinded Pilot Placebo-Controlled Trial With Oral Serum Bovine Immunoglobulin (SBI) to Assess Quality of Life and the Faster Post-Operative Recovery of Gynecological Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Female Reproductive Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| serum-derived bovine immunoglobulin protein isolate | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (serum-derived bovine immunoglobulin protein isolate)
- description
- 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.
- interventionNames
- Biological: serum-derived bovine immunoglobulin protein isolate
- Other: laboratory biomarker analysis
- Other: quality-of-life assessment
- Other: questionnaire administration
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- 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.
- interventionNames
- Other: placebo
- Other: laboratory biomarker analysis
- Other: quality-of-life assessment
- Other: questionnaire administration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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 * 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: * 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
References
Publications (0)
Data not yet available