MC1267, A Randomized, Blinded Phase II Placebo-Controlled Trial With Oral Serum Bovine Immunoglobulin (SBI) to Assess Quality of Life and the Faster Post-Operative Recovery of Gynecological Cancer Patients

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

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) 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. 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.

Who is eligible to participate?

Inclusion Criteria: - Diagnosis of gynecological cancer of any type - 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) - Total bilirubin =< 1.5 x ULN - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2 x 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

Last updated:
5/29/2013
NCT ID:
NCT01867606
IRB Number:
12-009448