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
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.
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.
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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Time-to-QOL improvement defined as any increase in the QOL score measured using the total score of the 14-item Postoperative Quality of Life (PQL) tool
The total score could range from 1 to 140 (0 being the worst and 140 being the best). The primary analysis will be a comparison of oral SBI vs. placebo using a two-sided log-rank test between the 2 Kaplan-Meier curves.
Baseline to 12 weeks
United States: Federal Government
|Mayo Clinic||Rochester, Minnesota 55905|